Pregabalin
- Product NDC
- 67877-469
- 11-digit product format
- 678770469
- Labeler code
- 67877
- Product ID
- 67877-469_a59cea51-015e-4eb2-bdd0-08fa82f32f75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA207799
- Marketing category
- ANDA
- Marketing start
- 2019-07-21
- Substance
- PREGABALIN
- Active strength
- 300 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-001 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-002 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-003 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-004 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-005 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-006 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-007 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-09-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-008 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-09-30 | 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 | 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… |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207799-008 | 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 | 300 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 55JG375S6M | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e48db3c2-7351-41f2-a451-5a8341c4125c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 441d8579-bd15-4585-93f4-9de3db2d851d | Product name | 4 | 20251114 |
| 004d1029-ec13-fc89-74f4-3907cf5b6602 | Product name | 2 | 20140523 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67877-469-05 | Pregabalin | 500 in 1 BOTTLE | CAPSULE | 500 | 18 | |
| 67877-469-30 | Pregabalin | 30 in 1 BOTTLE | CAPSULE | 30 | 18 | |
| 67877-469-33 | Pregabalin | 1 in 1 CARTON | CAPSULE | 1 | 18 | |
| 67877-469-33 | Pregabalin | 10 in 1 BLISTER PACK | CAPSULE | 10 | 18 | |
| 67877-469-38 | Pregabalin | 10 in 1 CARTON | CAPSULE | 10 | 18 | |
| 67877-469-38 | Pregabalin | 10 in 1 BLISTER PACK | CAPSULE | 10 | 18 | |
| 67877-469-90 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | 18 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67877-469-05 | EA - Each | 67877-469 | 102d6301-41bb-4e7c-92ef-f42d23243b99 | 1 | 2021-10-08 |
| 67877-469-90 | EA - Each | 67877-469 | b55897d1-1249-4d19-b098-5a3ed31f20f5 | 1 | 2019-08-06 |
DailyMed Dashboard NDC Coverage#
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 | REMEDYREPACK INC. | ab06a36d-9a2d-4eae-8991-4eab5bc8311c | 2026-09-11 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 12309847-0857-4ff7-a7e7-edeadc3dfb61 | 2026-08-14 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 47d08b8f-a24d-4159-ab43-2eb67a93559b | 2026-08-14 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 3c8ea6da-5771-4096-a915-700e51ced05c | 2026-08-14 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 9c38abbc-2b3d-48d6-b629-4a163c803db5 | 2026-08-14 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | efe06a26-30c5-437d-9fd1-4bd0062f1200 | 2026-08-14 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | Ascend Laboratories, LLC | e48db3c2-7351-41f2-a451-5a8341c4125c | 2026-08-04 | Warnings, Adverse reactions | 207799 ANDA207799 67877-469 |
| Pregabalin | PREGABALIN | St. Mary's Medical Park Pharmacy | 35d3486c-c6ea-4d31-e063-6294a90a1219 | 2026-06-30 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | St. Mary's Medical Park Pharmacy | 35d387dd-bc7f-37a4-e063-6394a90abbbb | 2026-06-30 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | Clinical Solutions Wholesale, LLC | 150c8b71-98b0-4c6b-b20f-fd0fca2d3c26 | 2026-06-11 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | ST. MARY'S MEDICAL PARK PHARMACY | 3dd7930b-f544-f18b-e063-6294a90a0541 | 2026-03-31 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | Clinical Solutions Wholesale, LLC | 613a7a13-d5ba-4827-91ec-3ed5176602b7 | 2026-02-13 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | b5b22ec1-3fd8-4631-ba7e-98d8e5d030b3 | 2025-10-02 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals Inc. | e8e272a4-c181-4573-822b-2bb315b6ad37 | 2025-09-12 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals Inc. | a0da0534-b386-4c93-ae89-03b0e3325e02 | 2025-09-11 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | c89a3514-f637-e54f-e053-2a95a90a6881 | 2024-12-31 | Warnings, Adverse reactions | 207799 ANDA207799 |
| PREGABALIN | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | d2813712-d7f6-6144-e053-2995a90a3c5d | 2024-11-20 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 4cda70e8-9ae1-4958-8c86-1bc633be982b | 2024-09-06 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | cf7f0fd0-bac2-4836-9363-79d32ad0cc10 | 2024-09-06 | Warnings, Adverse reactions | 207799 ANDA207799 |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 08ad87e3-e00c-46d1-98f8-df493cf1712e | 2024-09-06 | Warnings, Adverse reactions | 207799 ANDA207799 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67877-469-05 | 67877046905 | 500 CAPSULE in 1 BOTTLE (67877-469-05) | 500 capsule | 2019-07-21 | 0000-00-00 | No | No | Current |
| 67877-469-30 | 67877046930 | 30 CAPSULE in 1 BOTTLE (67877-469-30) | 30 capsule | 2019-07-21 | 0000-00-00 | No | No | Current |
| 67877-469-33 | 67877046933 | 1 BLISTER PACK in 1 CARTON (67877-469-33) / 10 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2019-07-21 | 0000-00-00 | No | No | Current |
| 67877-469-38 | 67877046938 | 10 BLISTER PACK in 1 CARTON (67877-469-38) / 10 CAPSULE in 1 BLISTER PACK | 10 blister pack | 2019-07-21 | 0000-00-00 | No | No | Current |
| 67877-469-90 | 67877046990 | 90 CAPSULE in 1 BOTTLE (67877-469-90) | 90 capsule | 2019-07-21 | 0000-00-00 | No | No | Current |