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Drug company (FDA labeler)

Sportpharm LLC

NDC labeler code: 85766

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

227Products (NDC)

Prescription medicines

Show the other 48 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.
  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
ApprovedApplicationMedicineSponsor
April 14, 2025ANDA215091 Allopurinol
ALLOPURINOL
Aurobindo Pharma Ltd
January 30, 2025NDA219209 Suzetrigine
JOURNAVX
Vertex Pharms Inc
January 27, 2025ANDA217886 Ipratropium bromide
IPRATROPIUM BROMIDE
Lupin
December 20, 2024ANDA217227 Tetracaine hydrochloride
TETRACAINE HYDROCHLORIDE
Somerset Theraps LLC
August 9, 2024ANDA215816 Proparacaine hydrochloride
PROPARACAINE HYDROCHLORIDE
Somerset Theraps LLC
August 9, 2024NDA214697 Epinephrine
NEFFY
Ars Pharms Operation
August 23, 2023ANDA217695 Dexamethasone
DEXAMETHASONE
Apotex
April 19, 2023ANDA217001 Dexamethasone
DEXAMETHASONE
Bionpharma
April 12, 2023ANDA215933 Loteprednol etabonate
LOTEPREDNOL ETABONATE
Sentiss
March 10, 2023ANDA216957 Clindamycin
CLINDAMYCIN HYDROCHLORIDE
Glenmark Pharms Ltd
February 9, 2023ANDA215243 Ramelteon
RAMELTEON
Micro Labs
November 2, 2022ANDA214456 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Alembic
September 23, 2022ANDA216275 Diclofenac
DICLOFENAC SODIUM
Ingenus Pharms LLC
July 14, 2022ANDA216130 Ofloxacin
OFLOXACIN
Mankind Pharma
January 31, 2022ANDA210459 Clarithromycin
CLARITHROMYCIN
Alembic
August 31, 2021ANDA213076 Mupirocin
MUPIROCIN
Encube
July 15, 2021ANDA204355 Diclofenac sodium and misoprostol
DICLOFENAC SODIUM AND MISOPROSTOL
Micro Labs
June 1, 2021ANDA207085 Albuterol sulfate
ALBUTEROL SULFATE
Sandoz
May 20, 2021ANDA212443 Ketoconazole
KETOCONAZOLE
Encube
February 11, 2021ANDA208412 Prednisone
PREDNISONE
Strides Pharma
December 3, 2020ANDA205129 Celecoxib
CELECOXIB
Sciegen Pharms
August 24, 2020ANDA206463 Lidocaine
LIDOCAINE
Amneal
August 24, 2020ANDA209954 Albuterol sulfate
ALBUTEROL SULFATE
Lupin
August 12, 2020ANDA213967 Methocarbamol
METHOCARBAMOL
Aurobindo Pharma Ltd
August 10, 2020ANDA205548 Ciprofloxacin and dexamethasone
CIPROFLOXACIN AND DEXAMETHASONE
DR Reddys
Show the other 100 applications
ApprovedApplicationMedicineSponsor
July 6, 2020ANDA213324 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Unichem
May 8, 2020ANDA213794 Ibuprofen
IBUPROFEN
Aurobindo Pharma Ltd
March 18, 2020ANDA209553 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE
Yiling
February 27, 2020NDA212728 Rimegepant sulfate
NURTEC ODT
Pfizer
February 24, 2020ANDA203760 Albuterol sulfate
ALBUTEROL SULFATE
Padagis Us
February 21, 2020ANDA212517 Naproxen
NAPROXEN
Sciegen Pharms
December 23, 2019NDA211765 Ubrogepant
UBRELVY
Abbvie
December 12, 2019ANDA207524 Tropicamide
TROPICAMIDE
Somerset Theraps LLC
July 24, 2019NDA210134 Glucagon
BAQSIMI
Amphastar Pharms Inc
May 20, 2019ANDA210043 Methylprednisolone acetate
METHYLPREDNISOLONE ACETATE
Amneal
April 30, 2019ANDA211604 Nitroglycerin
NITROGLYCERIN
Natco
April 5, 2019ANDA203410 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Micro Labs Ltd India
March 15, 2019ANDA205974 Acyclovir
ACYCLOVIR
Zydus Lifesciences
February 22, 2019ANDA211518 Benzonatate
BENZONATATE
Ascent Pharms Inc
December 19, 2018ANDA206948 Benzonatate
BENZONATATE
Puracap Pharm LLC
October 25, 2018ANDA208249 Azithromycin
AZITHROMYCIN
Cspc Ouyi
October 24, 2018NDA210854 Baloxavir marboxil
XOFLUZA
Genentech Inc
August 16, 2018ANDA090589 Epinephrine
EPINEPHRINE (AUTOINJECTOR)
Teva Pharms USA
June 27, 2018ANDA201835 Methylprednisolone acetate
METHYLPREDNISOLONE ACETATE
Sagent Pharms Inc
June 22, 2018ANDA208921 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE
Pharmobedient
June 15, 2018ANDA207636 Ropivacaine hydrochloride
ROPIVACAINE HYDROCHLORIDE
Somerset Theraps LLC
June 8, 2018ANDA209421 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE
Strides Pharma
May 31, 2018ANDA207774 Doxycycline
DOXYCYCLINE HYCLATE
Zydus Lifesciences
May 18, 2018ANDA209535 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Macleods Pharms
May 14, 2018ANDA204072 Methylprednisolone
METHYLPREDNISOLONE
Tianjin Tianyao
April 18, 2018ANDA208017 Lidocaine
LIDOCAINE HYDROCHLORIDE
Spectra Mdcl Devices
February 23, 2018ANDA209438 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE
Hetero Labs Ltd III
January 26, 2018ANDA210347 Piroxicam
PIROXICAM
Strides Pharma
December 11, 2017ANDA207550 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Amneal
October 30, 2017ANDA207182 Lidocaine
LIDOCAINE HYDROCHLORIDE
Eugia Pharma
June 28, 2017ANDA207444 Tobramycin
TOBRAMYCIN
Somerset Theraps LLC
June 15, 2017ANDA203695 Metaxalone
METAXALONE
Actavis Labs Fl Inc
May 31, 2017ANDA208170 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Rubicon Research
December 30, 2016ANDA204755 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Micro Labs Ltd India
November 22, 2016ANDA204770 Metaxalone
METAXALONE
Lannett Co Inc
November 16, 2016ANDA206560 Metronidazole
METRONIDAZOLE
Cadila
November 1, 2016ANDA204216 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Gland
September 20, 2016ANDA203375 Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Acella
July 13, 2016ANDA205612 Ropivacaine hydrochloride
ROPIVACAINE HYDROCHLORIDE
Eugia Pharma
June 29, 2016ANDA203702 Ceftriaxone sodium
CEFTRIAXONE
Qilu Antibiotics
May 13, 2016ANDA207183 Bupivacaine hydrochloride
BUPIVACAINE HYDROCHLORIDE
Eugia Pharma
March 16, 2016ANDA204590 Celecoxib
CELECOXIB
Macleods Pharms
December 21, 2015ANDA078845 Linezolid
LINEZOLID
Rising
December 21, 2015ANDA205517 Linezolid
LINEZOLID
Alkem Labs Ltd
December 11, 2015ANDA206503 Cyanocobalamin
CYANOCOBALAMIN
Somerset Theraps LLC
September 10, 2014ANDA202882 Pantoprazole sodium
PANTOPRAZOLE SODIUM
Hetero Labs Ltd V
September 8, 2014ANDA203711 Ondansetron
ONDANSETRON HYDROCHLORIDE
Qilu Pharm Hainan
January 29, 2014ANDA090495 Sumatriptan
SUMATRIPTAN SUCCINATE (AUTOINJECTOR)
DR Reddys
April 23, 2013ANDA202758 Sumatriptan
SUMATRIPTAN SUCCINATE
Eugia Pharma
March 14, 2013ANDA203082 Lidocaine
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Eugia Pharma
September 28, 2012ANDA201807 Indomethacin
INDOMETHACIN
Hetero Labs Ltd III
August 10, 2012NDA201739 Epinephrine
AUVI-Q
Kaleo Inc
July 25, 2012ANDA065489 Clarithromycin
CLARITHROMYCIN
Aurobindo
January 20, 2012ANDA091568 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Aurobindo Pharma Ltd
January 20, 2012ANDA091569 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Aurobindo Pharma Ltd
December 20, 2010ANDA090836 Cephalexin
CEPHALEXIN
Alkem Labs Ltd
May 24, 2010ANDA090682 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE
Aurobindo Pharma
April 21, 2010ANDA090227 Amoxicillin and clavulanate potassium (amoxicillin / amoxicillin sodium / clavulanate potassium)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Sandoz
April 12, 2010ANDA090469 Ondansetron
ONDANSETRON
Aurobindo Pharma
February 16, 2010ANDA090624 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Aurobindo Pharma
August 10, 2009ANDA078327 Sumatriptan
SUMATRIPTAN SUCCINATE
Aurobindo Pharma
May 28, 2009NDA022308 Besifloxacin
BESIVANCE
Bausch and Lomb
October 7, 2008ANDA077731 Fluconazole
FLUCONAZOLE
Aurobindo Pharma
September 24, 2008ANDA078420 Nabumetone
NABUMETONE
Sciegen Pharms
August 29, 2008ANDA040802 Dexamethasone
DEXAMETHASONE SODIUM PHOSPHATE
Mylan Labs Ltd
August 29, 2008ANDA040803 Dexamethasone
DEXAMETHASONE SODIUM PHOSPHATE
Mylan Labs Ltd
June 30, 2008ANDA077568 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE
Fdc Ltd
July 31, 2007ANDA078539 Ondansetron
ONDANSETRON HYDROCHLORIDE
Aurobindo Pharma
June 8, 2007ANDA077863 Diclofenac
DICLOFENAC SODIUM
Unique
January 31, 2007NDA021234 Diclofenac epolamine
FLECTOR
Ibsa
December 26, 2006ANDA077473 Ondansetron
ONDANSETRON HYDROCHLORIDE
Hospira
December 20, 2006ANDA077927 Meloxicam
MELOXICAM
Unichem
July 21, 2006NDA021929 Budesonide and formoterol fumarate dihydrate
SYMBICORT
Astrazeneca
November 25, 2005ANDA065229 Cephalexin
CEPHALEXIN
Lupin
November 18, 2005ANDA040596 Promethazine hydrochloride
PROMETHAZINE HYDROCHLORIDE
Zydus Pharms USA
November 14, 2005ANDA065211 Azithromycin
AZITHROMYCIN
Sandoz
November 14, 2005ANDA065223 Azithromycin
AZITHROMYCIN
Pliva
November 14, 2005ANDA065225 Azithromycin
AZITHROMYCIN
Pliva
November 9, 2005ANDA065271 Amoxicillin
AMOXICILLIN
Aurobindo
September 23, 2005ANDA065170 Mupirocin
MUPIROCIN
Sun Pharma Canada
May 9, 2005ANDA065169 Ceftriaxone sodium
CEFTRIAXONE
Sandoz
July 29, 2004ANDA076658 Fluconazole
FLUCONAZOLE
DR Reddys Labs Inc
May 30, 2003NDA020800 Epinephrine
ADRENACLICK, TWINJECT
Impax
April 11, 2003ANDA040491 Dexamethasone
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
Fresenius Kabi USA
March 18, 2002ANDA076067 Mometasone furoate
MOMETASONE FUROATE
Padagis Us
May 29, 2001ANDA075673 Clotrimazole and betamethasone dipropionate
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Taro
April 16, 2001ANDA075718 Famotidine
FAMOTIDINE
DR Reddys Labs Ltd
September 29, 2000NDA020833 Fluticasone propionate
FLOVENT DISKUS 100, FLOVENT DISKUS 250, FLOVENT DISKUS 50
Glaxo Grp Ltd
August 24, 2000NDA021077 Fluticasone propionate and salmeterol
ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, ADVAIR DISKUS 500/50
Glaxo Grp Ltd
October 27, 1999ANDA064134 Tobramycin and dexamethasone
TOBRAMYCIN AND DEXAMETHASONE
Bausch and Lomb Inc
March 19, 1999NDA020612 Lidocaine
LIDODERM
Teikoku Pharma USA
February 27, 1998ANDA040268 Prochlorperazine
PROCOMP
Jubilant Cadista
September 17, 1997ANDA074880 Albuterol sulfate
ALBUTEROL SULFATE
Nephron
May 16, 1997ANDA074754 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Teva
February 14, 1997ANDA064120 Polymyxin b sulfate and trimethoprim sulfate
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
Bausch and Lomb Inc
December 29, 1995ANDA064053 Neomycin sulfate, polymyxin b sulfate and hydrocortisone
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Bausch and Lomb Inc
September 29, 1995ANDA040074 Proparacaine hydrochloride
PROPARACAINE HYDROCHLORIDE
Bausch and Lomb Inc
September 30, 1994ANDA064076 Amoxicillin
AMOXICILLIN
Sandoz
July 29, 1994ANDA064067 Erythromycin
ERYTHROMYCIN
Bausch and Lomb Inc
July 27, 1994ANDA040064 Tropicamide
TROPICAMIDE
Bausch and Lomb

Showing the 125 newest of 151 applications. Full lists: Drugs@FDA →

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

Recall timeline

2026

  1. June 8, 2026 · Class II · Ongoing · D-0659-2026 · Lidocaine

    Lack of Assurance of Sterility

    Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01.

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 →