Pregabalin
- Product NDC
- 82804-299
- Requested package NDC
- 82804-299-60
- 11-digit product format
- 828040299
- Labeler code
- 82804
- Product ID
- 82804-299_57907c8d-31b3-4258-a824-0de48309eeec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA212988
- Marketing category
- ANDA
- Marketing start
- 2025-11-17
- Substance
- PREGABALIN
- Active strength
- 75 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212988-001 | PREGABALIN | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2022-03-08 | |
| A212988-002 | PREGABALIN | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2022-03-08 | |
| A212988-003 | PREGABALIN | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2022-03-08 | |
| A212988-004 | PREGABALIN | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2022-03-08 | |
| A212988-005 | PREGABALIN | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2022-03-08 | |
| A212988-006 | PREGABALIN | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2022-03-08 | |
| A212988-007 | PREGABALIN | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2022-03-08 | |
| A212988-008 | PREGABALIN | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2022-03-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212988-001 | AB |
| A212988-002 | AB |
| A212988-003 | AB |
| A212988-004 | AB |
| A212988-005 | AB |
| A212988-006 | AB |
| A212988-007 | AB |
| A212988-008 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212988-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2022-03-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212988-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2022-03-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212988-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2022-03-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212988-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2022-03-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212988-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2022-03-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212988-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2022-03-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212988-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2022-03-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212988-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2022-03-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A212988-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2022-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212988-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2022-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212988-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2022-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212988-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2022-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212988-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2022-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212988-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2022-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212988-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2022-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212988-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2022-03-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2022-03-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2022-03-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2022-03-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2022-03-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2022-03-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2022-03-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2022-03-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2022-03-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2022-03-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2022-03-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2022-03-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2022-03-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2022-03-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2022-03-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2022-03-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2022-03-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2022-03-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2022-03-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2022-03-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2022-03-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2022-03-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2022-03-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2022-03-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2022-03-08 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212988-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212988-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212988-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212988-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212988-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212988-006 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212988-007 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212988-008 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A212988-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212988-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212988-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212988-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212988-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212988-006 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212988-007 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212988-008 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212988-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212988-008 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212988-008 | AB | 1 | 6a471c1ec25d… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pregabalin
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PREGABALIN | 75 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 55JG375S6M | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 189b610e-3e29-42fa-ab6e-73effbe0d054 | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pregabalin | PREGABALIN | Proficient Rx LP | 189b610e-3e29-42fa-ab6e-73effbe0d054 | 2026-07-02 | Warnings, Adverse reactions | 212988 ANDA212988 82804-299-60 82804-299 82804029960 |
| Pregabalin | PREGABALIN | Proficient Rx LP | 34846423-e747-42c5-9bcd-f99c557c4f67 | 2026-05-01 | Warnings, Adverse reactions | 212988 ANDA212988 |
| PREGABALIN | PREGABALIN | Eskayef Pharmaceuticals Limited | 65d9e751-61c2-4741-85c0-2526cfdc765c | 2025-12-31 | Warnings, Adverse reactions | 212988 ANDA212988 |
| Pregabalin | PREGABALIN | Westminster Pharmaceuticals, LLC | 6b0ee2cf-52c3-4052-bea0-1458a4233745 | 2025-10-31 | Warnings, Adverse reactions | 212988 ANDA212988 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82804-299-60 | 82804029960 | 60 CAPSULE in 1 BOTTLE (82804-299-60) | 60 capsule | 2026-06-29 | No | No | Current |