Pregabalin
- Product NDC
- 69539-018
- Requested package NDC
- 69539-018-05
- 11-digit product format
- 695390018
- Labeler code
- 69539
- Product ID
- 69539-018_bc069afb-a7ac-4ac9-9b67-2b67f91b20ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- MSN LABORATORIES PRIVATE LIMITED
- Application
- ANDA209357
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Marketing end
- 0000-00-00
- Substance
- PREGABALIN
- Active strength
- 300 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 69539-018 | 69539-018-05 | D | Discontinued by firm | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69539-018 | 69539-018-05 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-008 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-008 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-006 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-007 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-008 | AB | 1 | b8a1b40f171c… |
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 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. | f30a7a3b-d45e-4e0b-ab1b-1369b2f02320 | 2026-08-06 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 326c643a-23c5-4dab-9266-abc22ca1f874 | 2026-08-06 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 91edbe87-cd22-43a5-9952-1cd523b13820 | 2026-07-29 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 14f3f9ba-7a4a-45d5-a25e-efe5cdff117d | 2026-07-28 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 44ec2918-4e0c-4e2d-9157-81295a15df57 | 2026-07-28 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | St. Mary's Medical Park Pharmacy | 36c3dda1-67fb-4dc5-e063-6294a90a1c3e | 2026-06-26 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | St. Mary's Medical Park Pharmacy | 2e6e6f9c-a14c-2d75-e063-6294a90a827e | 2026-06-20 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | ba3006b7-991f-4ae0-b908-5910e827e5bf | 2026-06-12 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 5290f7ad-6660-45ff-853d-6dcb947b570d | 2026-02-25 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | ST. MARY'S MEDICAL PARK PHARMACY | 4b94bfc1-88fc-2b5f-e063-6394a90a7077 | 2026-02-24 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | A-S Medication Solutions | 217c9f93-fe89-4684-8553-12ec9acaa507 | 2026-02-08 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | A-S Medication Solutions | 5d33e9c7-6d81-485b-bf4a-9a588eda5208 | 2026-02-08 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | A-S Medication Solutions | fa24fa02-e27d-476a-b6c4-93650aaaee68 | 2026-02-06 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | Advanced Rx of Tennessee, LLC | afc89689-bea9-92ec-e053-2995a90a7f21 | 2025-11-17 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | AvPAK | 40c0f658-2a0a-034b-e063-6394a90a1097 | 2025-10-09 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | Proficient Rx LP | 7d25bec8-b503-4f63-8995-372a6df58c72 | 2025-10-01 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | Novadoz Pharmaceuticals LLC | 193666f7-3c55-43b1-947a-2ffec40c687f | 2025-08-28 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | b1f4b888-ac88-4250-8db1-706e7cc01e93 | 2025-03-21 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | b0f34220-0657-4868-ae01-014f9300f622 | 2025-03-03 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | Proficient Rx LP | 580955ba-86f6-4e86-b0fa-dd44e8828b0e | 2025-03-01 | Warnings, Adverse reactions | 209357 ANDA209357 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69539-018-05 | 69539001805 | 500 CAPSULE in 1 BOTTLE (69539-018-05) | 500 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |