Drug company (FDA labeler)
Umedica Laboratories USA Inc.
NDC labeler code: 60290
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
- DiclofenacZipsor, Lofena, Cambia · 6 products
- CarbamazepineTegretol XR, Equetro, Carbatrol · 5 products
- TadalafilCialis, Tadliq, Adcirca · 4 products
- AtorvastatinLipitor · 4 products
- RosuvastatinCrestor · 4 products
- CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 4 products
- Olmesartan medoxomil and hydrochlorothiazideBenicar Hct · 3 products
- Sacubitril and valsartanEntresto · 3 products
- Olmesartan medoxomilBenicar · 3 products
- OxcarbazepineTrileptal, Oxtellar XR · 3 products
- SildenafilViagra, Vybrique, Revatio · 3 products
- Sertraline hydrochlorideZoloft · 2 products
- ChlorthalidoneThalitone, Hemiclor · 2 products
- RanolazineAspruzyo Sprinkle · 2 products
- Varenicline tartrateChantix, Tyrvaya · 2 products
- Zolpidem tartrateAmbien, Ambien CR, Edluar · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| August 5, 2026 | ANDA214551 | Ranolazine RANOLAZINE | Umedica |
| August 4, 2026 | ANDA219946 | Sacubitril and valsartan SACUBITRIL AND VALSARTAN | Umedica |
| May 12, 2026 | ANDA220717 | Zolpidem tartrate ZOLPIDEM TARTRATE | Umedica Labs Pvt |
| April 29, 2026 | ANDA218341 | Oxcarbazepine OXCARBAZEPINE | Umedica Labs Pvt |
| January 20, 2026 | ANDA218342 | Sertraline hydrochloride SERTRALINE HYDROCHLORIDE | Umedica |
| January 9, 2026 | ANDA218985 | Varenicline tartrate VARENICLINE TARTRATE | Umedica |
| November 5, 2025 | ANDA219945 | Diclofenac DICLOFENAC SODIUM | Umedica |
| August 29, 2025 | ANDA217010 | Diclofenac DICLOFENAC POTASSIUM | Umedica |
| August 18, 2022 | ANDA216594 | Carbamazepine CARBAMAZEPINE | Umedica |
| May 11, 2022 | ANDA215750 | Diclofenac DICLOFENAC POTASSIUM | Umedica |
| October 23, 2020 | ANDA211298 | Tadalafil TADALAFIL | Umedica |
| August 25, 2020 | ANDA209302 | Sildenafil SILDENAFIL CITRATE | Umedica |
| August 19, 2020 | ANDA213853 | Atorvastatin ATORVASTATIN CALCIUM | Umedica |
| April 15, 2020 | ANDA207798 | Carbamazepine CARBAMAZEPINE | Umedica |
| November 27, 2019 | ANDA210628 | Celecoxib CELECOXIB | Pharmazone |
| September 17, 2019 | ANDA208847 | Olmesartan medoxomil and hydrochlorothiazide OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Pharmazone |
| July 18, 2019 | ANDA207135 | Olmesartan medoxomil OLMESARTAN MEDOXOMIL | Pharmazone |
| April 9, 2019 | ANDA207626 | Rosuvastatin ROSUVASTATIN CALCIUM | Umedica |
| May 24, 2018 | ANDA207222 | Chlorthalidone CHLORTHALIDONE | Umedica |
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.
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