Drug company (FDA labeler)
Granules Pharmaceuticals Inc.
NDC labeler code: 70010
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.
Prescription medicines
- Lisdexamfetamine dimesylateVyvanse, Arynta · 13 products
- Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfateAdderall, Mixed Salts of a Single Entity Amphetamine Product XR, Adderall XR · 13 products
- Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 9 products
- Dexmethylphenidate hydrochlorideFocalin XR, Focalin · 8 products
- MethylphenidateMetadate Cd, Relexxii, Methylphenidate Hydrochloride Cd · 7 products
- Metformin hydrochlorideGlumetza · 7 products
- GabapentinNeurontin, Gralise, Relgaabi · 5 products
- BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 5 products
- Trazodone hydrochlorideRaldesy Tm · 4 products
- MetoprololToprol XL, Lopressor, Kapspargo · 4 products
- LevetiracetamKeppra, Spritam, Keppra XR · 4 products
- Oxycodone and acetaminophenEndocet, Prolate, Percocet · 4 products
- DofetilideTikosyn · 3 products
- Sertraline hydrochlorideZoloft · 3 products
- Losartan potassiumLosortan Potassium, Cozaar, Arbli · 3 products
- IbuprofenIbu, Caldolor · 3 products
- Prazosin hydrochloride3 products
- NaproxenNaprelan, Rugby All Day Relief · 3 products
- Venlafaxine hydrochlorideEffexor XR · 3 products
- Hydrocodone bitartrate and acetaminophenNorco · 3 products
- Losartan potassium and hydrochlorothiazideHyzaar · 3 products
- Butalbital, acetaminophen and caffeineFioricet · 2 products
- EsomeprazoleNexium · 2 products
- MethocarbamolRobaxin, Atmeksi, Tanlor · 2 products
- Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 2 products
- AmphetamineAdzenys Xr-Odt, Dyanavel XR, Evekeo · 2 products
- ColchicineColcrys, Gloperba, Lodoco · 1 product
- GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 1 product
- Trospium chloride1 product
- ValganciclovirValcyte · 1 product
- RamelteonRozerem · 1 product
- Butalbital and acetaminophenTencon, Allzital · 1 product
- Methylergonovine maleateMethergine · 1 product
- PenicillamineAagylur, Depen, Cuprimine · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| January 29, 2025 | ANDA218987 | Lisdexamfetamine dimesylate LISDEXAMFETAMINE DIMESYLATE | Granules |
| December 16, 2024 | ANDA219258 | Lisdexamfetamine dimesylate LISDEXAMFETAMINE DIMESYLATE | Granules |
| October 17, 2024 | ANDA218385 | Bupropion BUPROPION HYDROCHLORIDE | Granules |
| August 19, 2024 | ANDA214735 | Glycopyrrolate GLYCOPYRROLATE | Granules |
| August 8, 2024 | ANDA218988 | Trazodone hydrochloride TRAZODONE HYDROCHLORIDE | Granules |
| December 11, 2023 | ANDA217282 | Pantoprazole sodium PANTOPRAZOLE SODIUM | Granules |
| October 18, 2023 | ANDA217427 | Esomeprazole ESOMEPRAZOLE MAGNESIUM | Granules |
| September 29, 2023 | ANDA218015 | Losartan potassium and hydrochlorothiazide LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Granules |
| June 13, 2023 | ANDA217878 | Levetiracetam LEVETIRACETAM | Granules |
| June 12, 2023 | ANDA216916 | Metoprolol METOPROLOL SUCCINATE | Granules |
| May 18, 2023 | ANDA217390 | Venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE | Granules |
| March 28, 2023 | ANDA217116 | Gabapentin GABAPENTIN | Granules |
| February 23, 2023 | ANDA215959 | Losartan potassium LOSARTAN POTASSIUM | Granules |
| January 23, 2023 | ANDA217027 | Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | Granules |
| February 2, 2022 | ANDA215568 | Bupropion BUPROPION HYDROCHLORIDE | Granules |
| January 27, 2022 | ANDA213467 | Potassium chloride POTASSIUM CHLORIDE | Granules |
| December 28, 2021 | ANDA215771 | Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | Granules |
| December 23, 2021 | ANDA214608 | Prazosin hydrochloride PRAZOSIN HYDROCHLORIDE | Granules |
| October 14, 2021 | ANDA212750 | Dofetilide DOFETILIDE | Granules |
| February 16, 2021 | ANDA214686 | Potassium chloride POTASSIUM CHLORIDE | Granules |
| January 29, 2021 | ANDA213392 | Potassium chloride POTASSIUM CHLORIDE | Granules |
| January 14, 2021 | ANDA213344 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Granules |
| December 2, 2020 | ANDA211735 | Penicillamine PENICILLAMINE | Granules |
| October 21, 2020 | ANDA214452 | Potassium chloride POTASSIUM CHLORIDE | Granules |
| September 9, 2020 | ANDA213813 | Dexmethylphenidate hydrochloride DEXMETHYLPHENIDATE HYDROCHLORIDE | Granules |
Show the other 21 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| August 21, 2020 | ANDA213186 | Ramelteon RAMELTEON | Granules |
| April 23, 2020 | ANDA213185 | Trospium chloride TROSPIUM CHLORIDE | Granules |
| April 8, 2020 | ANDA213321 | Butalbital, acetaminophen and caffeine BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Granules |
| March 4, 2020 | ANDA211797 | Potassium chloride POTASSIUM CHLORIDE | Granules |
| February 5, 2020 | ANDA210425 | Colchicine COLCHICINE | Granules |
| January 31, 2020 | ANDA213306 | Valganciclovir VALGANCICLOVIR HYDROCHLORIDE | Granules |
| January 3, 2020 | ANDA211729 | Hydrocodone bitartrate and acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Granules |
| November 22, 2019 | ANDA213115 | Butalbital and acetaminophen BUTALBITAL AND ACETAMINOPHEN | Granules |
| October 31, 2019 | ANDA211708 | Oxycodone and acetaminophen OXYCODONE AND ACETAMINOPHEN | Granules |
| August 5, 2019 | ANDA212619 | Amphetamine AMPHETAMINE SULFATE | Granules |
| May 23, 2019 | ANDA211796 | Methylphenidate METHYLPHENIDATE HYDROCHLORIDE | Granules |
| November 21, 2018 | ANDA210992 | Methylphenidate METHYLPHENIDATE HYDROCHLORIDE | Granules |
| May 15, 2018 | ANDA210424 | Methylergonovine maleate METHYLERGONOVINE MALEATE | Granules |
| May 7, 2018 | ANDA209312 | Methocarbamol METHOCARBAMOL | Granules |
| March 16, 2018 | ANDA209313 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Granules |
| September 15, 2015 | ANDA091625 | Ibuprofen IBUPROFEN | Granules |
| April 22, 2010 | ANDA090564 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Granules India |
| December 1, 2008 | ANDA040864 | Butalbital, acetaminophen and caffeine BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Granules |
| January 8, 2008 | ANDA078403 | Sertraline hydrochloride SERTRALINE HYDROCHLORIDE | Granules |
| April 6, 2005 | ANDA075360 | Gabapentin GABAPENTIN | Granules |
| December 21, 1993 | ANDA074140 | Naproxen NAPROXEN | Granules |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026