Active ingredient
Pregabalin
542 finished FDA listings contain Pregabalin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PREGABALIN
- Dosage forms
- Capsule, Solution, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 56
- Strengths listed
- 100 mg/1 · 150 mg/1 · 165 mg/1 · 20 mg/ml · 200 mg/1 · 225 mg/1 · 25 mg/1 · 300 mg/1 · 330 mg/1 · 50 mg/1 · 75 mg/1 · 82.5 mg/1
- Brand names in FDA listings
- Lyrica, Lyrica Cr, Pregabalin Extended Release
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 187832
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021446 | UPJOHN | 2004-12-30 | 9 |
| NDA 022488 | UPJOHN | 2010-01-04 | 2 |
| NDA 209501 | UPJOHN | 2017-10-11 | 3 |
| ANDA 209357 | MSN | 2019-07-19 | 37 |
| ANDA 209743 | AMNEAL PHARMS CO | 2019-07-19 | 27 |
| ANDA 208677 | SCIEGEN PHARMS | 2019-07-19 | 134 |
| ANDA 211384 | INVAGEN PHARMS | 2019-07-19 | 24 |
| ANDA 207623 | ALKEM LABS LTD | 2019-07-19 | 1 |
| ANDA 203459 | ALEMBIC | 2019-07-19 | 16 |
| ANDA 209664 | DR REDDYS | 2019-07-19 | 8 |
| ANDA 210432 | RISING | 2019-07-19 | 48 |
| ANDA 207799 | ALKEM LABS LTD | 2019-07-19 | 37 |
| ANDA 206912 | HETERO LABS LTD III | 2019-10-08 | 40 |
| ANDA 091157 | SUN PHARM | 2019-11-29 | 8 |
| ANDA 212280 | CIPLA | 2020-01-10 | 8 |
| ANDA 212865 | CHARTWELL RX | 2020-03-20 | 4 |
| ANDA 213423 | CREEKWOOD PHARMS | 2020-03-23 | 8 |
| ANDA 213226 | MSN | 2021-04-13 | 3 |
| ANDA 214322 | CHANGZHOU PHARM | 2021-07-15 | 7 |
| ANDA 212604 | ANDA REPOSITORY | 2022-02-18 | 1 |
| ANDA 212988 | PHARMAZONE | 2022-03-08 | 26 |
| ANDA 215249 | RUBICON RESEARCH | 2022-03-22 | 3 |
| ANDA 216197 | MARKSANS PHARMA | 2022-07-18 | 8 |
| ANDA 207883 | PRINSTON INC | 2022-09-01 | 8 |
| ANDA 215675 | SCIEGEN PHARMS | 2022-09-14 | 3 |
| ANDA 205321 | AUROBINDO PHARMA | 2023-03-29 | 20 |
| ANDA 206452 | CADILA PHARMS LTD | 2023-07-12 | 8 |
| ANDA 208113 | REGCON HOLDINGS | 2024-05-17 | 8 |
| ANDA 205924 | MACLEODS PHARMS | 2024-11-12 | 8 |
| ANDA 206942 | TORRENT | 2025-02-21 | 9 |
| ANDA 218529 | CAPLIN | 2026-02-24 | 8 |
| ANDA 219593 | UNICHEM | 2026-04-30 | 8 |
Official labeling on DailyMed
- PREGABALIN CAPSULE [REMEDYREPACK INC.] · version 3 · 2026-09-14
- PREGABALIN CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC] · version 1 · 2026-09-10
- PREGABALIN CAPSULE [REMEDYREPACK INC.] · version 3 · 2026-09-07
- PREGABALIN CAPSULE [REMEDYREPACK INC.] · version 1 · 2026-09-03
- PREGABALIN CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY] · version 5 · 2026-09-02
- PREGABALIN CAPSULE [PREFERRED PHARMACEUTICALS INC.] · version 4 · 2026-08-24
- PREGABALIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.] · version 7 · 2026-08-24
- PREGABALIN CAPSULE [REMEDYREPACK INC.] · version 9 · 2026-08-21
- PREGABALIN CAPSULE [REMEDYREPACK INC.] · version 9 · 2026-08-17
- PREGABALIN CAPSULE [PROFICIENT RX LP] · version 3 · 2026-08-17
- PREGABALIN CAPSULE [REMEDYREPACK INC.] · version 9 · 2026-08-17
- PREGABALIN CAPSULE [REMEDYREPACK INC.] · version 9 · 2026-08-17
Showing the 12 most recent of 228 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.