Pregabalin
- Product NDC
- 58118-1462
- 11-digit product format
- 581181462
- Labeler code
- 58118
- Product ID
- 58118-1462_5400e445-c66c-2af3-e063-6294a90aca30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Clinical Solutions Wholesale, LLC
- Application
- ANDA207799
- Marketing category
- ANDA
- Marketing start
- 2019-10-02
- Substance
- PREGABALIN
- Active strength
- 25 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 |
|---|---|---|---|---|---|---|---|
| A207799-001 | PREGABALIN | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A207799-002 | PREGABALIN | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A207799-003 | PREGABALIN | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A207799-004 | PREGABALIN | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A207799-005 | PREGABALIN | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A207799-006 | PREGABALIN | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A207799-007 | PREGABALIN | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-09-30 | |
| A207799-008 | PREGABALIN | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-09-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207799-001 | AB |
| A207799-002 | AB |
| A207799-003 | AB |
| A207799-004 | AB |
| A207799-005 | AB |
| A207799-006 | AB |
| A207799-007 | AB |
| A207799-008 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A207799-001 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A207799-002 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A207799-003 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A207799-004 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A207799-005 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A207799-006 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A207799-007 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-09-30 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A207799-008 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-09-30 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A207799-001 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207799-002 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207799-003 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207799-004 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207799-005 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207799-006 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207799-007 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-09-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207799-008 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-09-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A207799-001 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207799-002 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207799-003 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207799-004 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207799-005 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207799-006 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207799-007 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-09-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207799-008 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-09-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-001 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-002 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-003 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-004 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-005 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-006 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-007 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-09-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-008 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-09-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-001 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-002 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-003 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-004 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-005 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-006 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-007 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-09-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-008 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-09-30 | 31067a03dcf5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A207799-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A207799-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A207799-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A207799-004 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A207799-005 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A207799-006 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A207799-007 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A207799-008 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A207799-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207799-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207799-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207799-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207799-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207799-006 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207799-007 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207799-008 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A207799-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207799-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207799-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207799-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207799-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207799-006 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207799-007 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207799-008 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207799-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207799-008 | AB | 1 | 31067a03dcf5… |
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 | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 55JG375S6M | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 483442 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 150c8b71-98b0-4c6b-b20f-fd0fca2d3c26 | 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 | Bryant Ranch Prepack | 8923d776-b374-4c06-a208-abeffb1ba578 | 2024-09-06 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | Proficient Rx LP | 68829d7b-ab40-429e-92dc-91f8a0d49afd | 2022-07-01 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | Proficient Rx LP | a1545bbb-b337-4760-ab4c-fb76ab019337 | 2022-05-02 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | Proficient Rx LP | 1503dd3b-688b-4702-8fc1-954b5ffe4235 | 2022-05-02 | Warnings, Adverse reactions | 207799 ANDA207799 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58118-1462-8 | 58118146208 | 30 CAPSULE in 1 BLISTER PACK (58118-1462-8) | 30 capsule | 2019-10-02 | No | No | Current |