Drug company (FDA labeler)
Indoco Remedies Limited
NDC labeler code: 14445
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
- PregabalinLyrica, Lyrica CR · 8 products
- LacosamideVimpat, Motpoly XR · 5 products
- RivaroxabanXarelto · 4 products
- AllopurinolAloprim · 3 products
- Varenicline tartrateChantix, Tyrvaya · 2 products
- ApixabanEliquis, Eliquis Sprinkle · 2 products
- Neostigmine methylsulfateBloxiverz · 2 products
- Dorzolamide hydrochloride and timolol maleateCosopt, Dorzolamide Hydrochloride Timolol Maletae, Cosopt Pf · 1 product
- SuccinylcholineAnectine, Quelicin · 1 product
- Brimonidine tartrateAlphagan P, Mirvaso · 1 product
- AcetylcysteineAcetadote · 1 product
- Lofexidine hydrochlorideLucemyra · 1 product
- Dorzolamide hydrochloride1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| August 11, 2025 | ANDA218445 | Rivaroxaban RIVAROXABAN | Regcon Holdings |
| October 29, 2024 | ANDA219106 | Varenicline tartrate VARENICLINE TARTRATE | Regcon Holdings |
| August 20, 2024 | ANDA218613 | Lofexidine hydrochloride LOFEXIDINE HYDROCHLORIDE | Regcon Holdings |
| May 17, 2024 | ANDA208113 | Pregabalin PREGABALIN | Regcon Holdings |
| April 7, 2022 | ANDA214301 | Lacosamide LACOSAMIDE | Regcon Holdings |
| March 17, 2022 | ANDA208308 | Lacosamide LACOSAMIDE | Regcon Holdings |
| February 23, 2022 | ANDA215620 | Acetylcysteine ACETYLCYSTEINE | Regcon Holdings |
| October 1, 2021 | ANDA210652 | Neostigmine methylsulfate NEOSTIGMINE METHYLSULFATE | Regcon Holdings |
| September 11, 2020 | ANDA209898 | Apixaban APIXABAN | Regcon Holdings |
| May 22, 2020 | ANDA214308 | Succinylcholine SUCCINYLCHOLINE CHLORIDE | Regcon Holdings |
| July 28, 2016 | ANDA204467 | Allopurinol ALLOPURINOL | Regcon Holdings |
| November 18, 2014 | ANDA091691 | Brimonidine tartrate BRIMONIDINE TARTRATE | Regcon Holdings |
| September 11, 2014 | ANDA202053 | Dorzolamide hydrochloride DORZOLAMIDE HYDROCHLORIDE | Regcon Holdings |
| September 3, 2014 | ANDA202054 | Dorzolamide hydrochloride and timolol maleate DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | Regcon Holdings |
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