Pregabalin
- Product NDC
- 70518-4778
- Requested package NDC
- 70518-4778-0
- 11-digit product format
- 705184778
- Labeler code
- 70518
- Product ID
- 70518-4778_5e30fd81-aa08-31d6-e063-6294a90ada01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209357
- Marketing category
- ANDA
- Marketing start
- 2026-10-19
- Substance
- PREGABALIN
- Active strength
- 225 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 |
|---|---|---|---|---|---|---|---|
| A209357-001 | PREGABALIN | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209357-002 | PREGABALIN | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209357-003 | PREGABALIN | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209357-004 | PREGABALIN | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209357-005 | PREGABALIN | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209357-006 | PREGABALIN | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209357-007 | PREGABALIN | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209357-008 | PREGABALIN | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209357-001 | AB |
| A209357-002 | AB |
| A209357-003 | AB |
| A209357-004 | AB |
| A209357-005 | AB |
| A209357-006 | AB |
| A209357-007 | AB |
| A209357-008 | 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 | A209357-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A209357-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A209357-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A209357-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A209357-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A209357-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A209357-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A209357-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A209357-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209357-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209357-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209357-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209357-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209357-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209357-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209357-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A209357-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209357-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209357-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209357-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209357-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209357-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209357-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209357-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | 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 | A209357-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209357-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209357-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209357-004 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209357-005 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209357-006 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209357-007 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209357-008 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A209357-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209357-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209357-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209357-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209357-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209357-006 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209357-007 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209357-008 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A209357-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209357-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209357-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209357-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209357-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209357-006 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209357-007 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209357-008 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-008 | 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 | 225 mg/1 |
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 | Aphena Pharma Solutions - Tennessee, LLC | 4ed3e73c-13e7-4646-874d-276b6c75d2c9 | 2024-02-08 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | d2a98872-1a52-47e1-b4bd-0ff7d6272a92 | 2023-12-01 | Warnings, Adverse reactions | 209357 ANDA209357 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-4778-0 | 70518477800 | 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-4778-0) | 90 capsule | 2026-10-19 | No | No | Current |