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Drug company (FDA labeler)

Strides Pharma Science Limited

NDC labeler code: 64380

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

66Prescription medicines
182Products (NDC)
85FDA applications
15Recalls

Prescription medicines

Show the other 26 medicines

FDA applications for these products

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
April 29, 2025ANDA213127 Celecoxib
CELECOXIB		Strides Pharma
September 13, 2024ANDA212683 Fluoxetine
FLUOXETINE HYDROCHLORIDE		Strides Pharma
September 5, 2024ANDA215312 Theophylline
THEOPHYLLINE		Strides Pharma
May 21, 2024ANDA216474 Sucralfate
SUCRALFATE		Strides Pharma
May 9, 2024ANDA211915 Sevelamer carbonate
SEVELAMER CARBONATE		Strides Pharma
April 5, 2024ANDA212684 Fluoxetine
FLUOXETINE HYDROCHLORIDE		Strides Pharma
November 22, 2023ANDA215469 Sodium sulfate, potassium sulfate, magnesium sulfate
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE		Strides Pharma Intl
September 8, 2023ANDA211917 Sevelamer carbonate
SEVELAMER CARBONATE		Strides Pharma Intl
August 29, 2023ANDA212634 Mycophenolate mofetil
MYCOPHENOLATE MOFETIL		Strides Pharma Intl
August 2, 2022ANDA216046 Cyclosporine
CYCLOSPORINE		Onesource
May 27, 2022ANDA215311 Ibuprofen
IBUPROFEN		Strides Pharma
February 18, 2022ANDA211354 Amantadine
AMANTADINE HYDROCHLORIDE		Onesource
January 13, 2022ANDA211894 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE		Strides Pharma
March 11, 2021ANDA211667 Potassium chloride
POTASSIUM CHLORIDE		Strides Pharma
February 18, 2021ANDA079021 Atomoxetine
ATOMOXETINE HYDROCHLORIDE		Strides Pharma
February 11, 2021ANDA208412 Prednisone
PREDNISONE		Strides Pharma
January 22, 2021ANDA210344 Ursodiol
URSODIOL		Strides Pharma
January 13, 2021ANDA091055 Emtricitabine and tenofovir disoproxil fumarate
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE		Strides Pharma
December 17, 2020ANDA208165 Oxybutynin
OXYBUTYNIN CHLORIDE		Strides Pharma
September 2, 2020ANDA210785 Prednisone
PREDNISONE		Strides Pharma
August 20, 2020ANDA213504 Ursodiol
URSODIOL		Strides Pharma
July 24, 2020ANDA202510 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE		Strides Pharma Intl
June 1, 2020ANDA212356 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE		Strides Pharma
December 16, 2019ANDA212670 Zileuton
ZILEUTON		Strides Pharma Intl
December 3, 2019ANDA210078 Diclofenac
DICLOFENAC POTASSIUM		Onesource
Show the other 60 applications
ApprovedApplicationMedicineSponsor
February 19, 2019ANDA211928 Ethosuximide
ETHOSUXIMIDE		Onesource
December 21, 2018ANDA204558 Polyethylene glycol 3350 and electrolytes - unflavored, Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES		Strides Pharma
October 16, 2018ANDA211314 Gabapentin
GABAPENTIN		Strides Pharma
August 31, 2018ANDA210733 Potassium chloride
POTASSIUM CHLORIDE		Strides Pharma
June 18, 2018ANDA210457 Ketoconazole
KETOCONAZOLE		Strides Pharma
June 8, 2018ANDA209421 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE		Strides Pharma
May 14, 2018ANDA206943 Gabapentin
GABAPENTIN		Strides Pharma
April 30, 2018ANDA209226 Cinacalcet
CINACALCET HYDROCHLORIDE		Strides Pharma
April 19, 2018ANDA090457 Lamivudine
LAMIVUDINE		Strides Pharma
April 11, 2018ANDA209172 Cyproheptadine
CYPROHEPTADINE HYDROCHLORIDE		Strides Pharma Intl
January 26, 2018ANDA090742 Tenofovir disoproxil fumarate
TENOFOVIR DISOPROXIL FUMARATE		Strides Pharma
January 26, 2018ANDA210347 Piroxicam
PIROXICAM		Strides Pharma
November 20, 2017ANDA209734 Acetazolamide
ACETAZOLAMIDE		Strides Pharma
September 19, 2017ANDA203893 OMEGA-3-ACID ethyl esters
OMEGA-3-ACID ETHYL ESTERS		Onesource
April 27, 2017ANDA207029 Hydrocortisone
HYDROCORTISONE		Strides Pharma
June 15, 2016ANDA202935 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN		Strides Pharma Intl
November 20, 2015ANDA204262 Dutasteride
DUTASTERIDE		Onesource
July 30, 2015ANDA091133 Benzonatate
BENZONATATE		Onesource Specialty
June 1, 2015ANDA201087 Amlodipine besylate valsartan hydrochlorothiazide
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE		Strides Pharma Intl
April 13, 2015ANDA204559 Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE		Strides Pharma
December 12, 2014ANDA091356 Calcitriol
CALCITRIOL		Onesource Specialty
November 4, 2014ANDA200790 Valganciclovir
VALGANCICLOVIR HYDROCHLORIDE		Strides Pharma Intl
August 25, 2014ANDA202330 Buspirone
BUSPIRONE HYDROCHLORIDE		Strides Pharma
July 22, 2014ANDA090687 Tacrolimus
TACROLIMUS		Strides Pharma
June 5, 2014ANDA202687 Methoxsalen
METHOXSALEN		Onesource
June 3, 2014ANDA202702 Pramipexole dihydrochloride
PRAMIPEXOLE DIHYDROCHLORIDE		Strides Pharma
July 12, 2013ANDA203244 Gabapentin
GABAPENTIN		Strides Pharma
May 3, 2013ANDA200770 Hydralazine hydrochloride
HYDRALAZINE HYDROCHLORIDE		Strides Pharma
April 19, 2013ANDA079182 Omeprazole and sodium bicarbonate
OMEPRAZOLE AND SODIUM BICARBONATE		Strides Pharma Intl
April 9, 2012ANDA065490 Vancomycin
VANCOMYCIN HYDROCHLORIDE		Strides Pharma
November 28, 2011ANDA202075 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE		Strides Pharma
October 24, 2011ANDA078109 Olanzapine
OLANZAPINE		Strides Pharma Intl
July 27, 2011ANDA090912 Acarbose
ACARBOSE		Strides Pharma
October 6, 2010ANDA090382 Losartan potassium
LOSARTAN POTASSIUM		Strides Pharma
August 3, 2010ANDA090455 Ergocalciferol
ERGOCALCIFEROL		Onesource
June 10, 2010ANDA090055 Mycophenolate mofetil
MYCOPHENOLATE MOFETIL		Strides Pharma
June 10, 2010ANDA090314 Sumatriptan
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE (AUTOINJECTOR)		Onesource Specialty
June 10, 2010ANDA090456 Mycophenolate mofetil
MYCOPHENOLATE MOFETIL		Strides Pharma
September 9, 2009ANDA077463 Nateglinide
NATEGLINIDE		Strides Pharma Intl
February 5, 2009ANDA078329 Ibuprofen
IBUPROFEN		Strides Pharma
May 23, 2007ANDA076744 Testosterone
TESTOSTERONE		Strides Pharma Intl
January 31, 2007ANDA077712 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE		Strides Pharma Intl
June 29, 2006ANDA040640 Tranylcypromine sulfate
TRANYLCYPROMINE SULFATE		Strides Pharma Intl
April 16, 2003ANDA065131 Minocycline hydrochloride
MINOCYCLINE HYDROCHLORIDE		Strides Pharma Intl
October 17, 2002ANDA075938 Propafenone hydrochloride
PROPAFENONE HYDROCHLORIDE		Strides Pharma Intl
July 25, 2001ANDA075671 Megestrol acetate
MEGESTROL ACETATE		Strides Pharma Intl
December 15, 2000ANDA065070 Doxycycline
DOXYCYCLINE		Strides Pharma Intl
December 1, 2000ANDA065055 Doxycycline
DOXYCYCLINE		Strides Pharma Intl
March 29, 2000ANDA040350 Methimazole
METHIMAZOLE		Mylan
October 31, 1997ANDA075079 Oxybutynin
OXYBUTYNIN CHLORIDE		Strides Pharma Intl
September 26, 1996NDA020547 Zafirlukast
ACCOLATE		Strides Pharma Intl
September 30, 1988ANDA089805 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE		Strides Pharma Intl
September 30, 1988ANDA089828 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE		Strides Pharma Intl
September 30, 1988ANDA089990 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE		Strides Pharma Intl
August 8, 1988ANDA072422 Megestrol acetate
MEGESTROL ACETATE		Strides Pharma Intl
August 8, 1988ANDA072423 Megestrol acetate
MEGESTROL ACETATE		Strides Pharma Intl
April 7, 1986ANDA062538 Doxycycline
DOXYCYCLINE HYCLATE		Strides Pharma Intl
October 21, 1983ANDA088262 Imipramine
IMIPRAMINE HYDROCHLORIDE		Strides Pharma Intl
October 21, 1983ANDA088276 Imipramine
IMIPRAMINE HYDROCHLORIDE		Strides Pharma Intl
October 21, 1983ANDA088292 Imipramine
IMIPRAMINE HYDROCHLORIDE		Strides Pharma Intl

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2026

  1. April 30, 2026 · Class II · Ongoing · D-0538-2026 · Atomoxetine

    Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

    Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01

2025

  1. July 9, 2025 · Class II · Ongoing · D-0546-2025 · Cinacalcet

    Failed Dissolution Specifications.

    Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04

  2. March 5, 2025 · Class II · Ongoing · D-0294-2025 · Testosterone

    Presence of foreign substance: Presence of Benzene.

    Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02

  3. March 5, 2025 · Class II · Ongoing · D-0293-2025 · Testosterone

    Presence of foreign substance: Presence of Benzene.

    Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02

2023

  1. December 29, 2023 · Class II · Terminated · D-0260-2024 · Methoxsalen

    Failed Dissolution Specifications

    Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-752-16

  2. June 26, 2023 · Class II · Terminated · D-0895-2023 · Losartan potassium

    Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.

    Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipur

2022

  1. July 19, 2022 · Class II · Terminated · D-1330-2022 · Prednisone

    Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets

    Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.

  2. May 18, 2022 · Class II · Terminated · D-0973-2022 · Losartan potassium

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Dist

  3. May 18, 2022 · Class II · Terminated · D-0972-2022 · Losartan potassium

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distr

  4. May 18, 2022 · Class II · Terminated · D-0974-2022 · Losartan potassium

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Dis

Show the 5 older recalls

2021

  1. September 27, 2021 · Class II · Terminated · D-0006-2022 · Potassium chloride

    Failed Dissolution Specifications

    Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, ND

2020

  1. December 22, 2020 · Class III · Terminated · D-0180-2021 · Tacrolimus

    Failed Moisture Limits

    NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816

  2. August 24, 2020 · Class II · Terminated · D-0001-2021 · Potassium chloride

    Failed Dissolution Specifications

    Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Science Limited Bengaluru -562106 India Distributed by: Strides Pharma Inc., East Brun

  3. February 17, 2020 · Class III · Terminated · D-1029-2020 · Potassium chloride

    Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.

    Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816

2017

  1. May 9, 2017 · Class III · Terminated · D-0858-2017 · Benzonatate

    Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.

    Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

FDA Enforcement Report search → · Report an error →