Pregabalin
- Product NDC
- 70518-2571
- Requested package NDC
- 70518-2571-1
- 11-digit product format
- 705182571
- Labeler code
- 70518
- Product ID
- 70518-2571_f0826469-8b81-7a27-e053-2995a90a8378
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209743
- Marketing category
- ANDA
- Marketing start
- 2020-02-07
- Marketing end
- 0000-00-00
- Substance
- PREGABALIN
- Active strength
- 50 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 | 70518-2571 | 70518-2571-1 | D | Discontinued by firm | 2026-09-09 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209743-001 | PREGABALIN | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209743-002 | PREGABALIN | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209743-003 | PREGABALIN | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209743-004 | PREGABALIN | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209743-005 | PREGABALIN | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209743-006 | PREGABALIN | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209743-007 | PREGABALIN | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209743-008 | PREGABALIN | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209743-001 | AB |
| A209743-002 | AB |
| A209743-003 | AB |
| A209743-004 | AB |
| A209743-005 | AB |
| A209743-006 | AB |
| A209743-007 | AB |
| A209743-008 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A209743-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209743-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209743-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209743-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209743-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209743-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209743-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209743-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A209743-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209743-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209743-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209743-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209743-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209743-006 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209743-007 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209743-008 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209743-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209743-008 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209743-008 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209743-008 | AB | 1 | fd3edfee7708… |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-2571 | PREGABALIN CAPSULE [REMEDYREPACK INC.] | 11 | Legacy NDC | 20250321_814a5454-311d-47e9-9e69-d7eb3db65bc6.zip |
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. | d095accf-9cea-4948-b43d-ae1b8fbce7c2 | 2026-08-20 | Warnings, Adverse reactions | 209743 ANDA209743 |
| Pregabalin | PREGABALIN | Amneal Pharmaceuticals NY LLC | 3d9d7123-5886-4b61-a7ea-471b213e77d9 | 2026-04-14 | Warnings, Adverse reactions | 209743 ANDA209743 |
| Pregabalin | PREGABALIN | Amneal Pharmaceuticals NY LLC | 3099759f-cb24-40e8-b482-9388c38c73b9 | 2025-06-19 | Warnings, Adverse reactions | 209743 ANDA209743 |
| PREGABALIN | PREGABALIN | Direct_Rx | 91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d | 2025-01-17 | Warnings, Adverse reactions | 209743 ANDA209743 |
| Pregabalin | PREGABALIN | Advanced Rx of Tennessee, LLC | afc89ca3-5597-1c75-e053-2a95a90a3ff2 | 2024-12-31 | Warnings, Adverse reactions | 209743 ANDA209743 |
| Pregabalin | PREGABALIN | Advanced Rx of Tennessee, LLC | af739a0d-a3cd-754f-e053-2a95a90ad655 | 2024-12-31 | Warnings, Adverse reactions | 209743 ANDA209743 |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | b8172d6b-a646-e559-e053-2a95a90ac24d | 2024-12-31 | Warnings, Adverse reactions | 209743 ANDA209743 |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | bc1b143d-feaf-9498-e053-2995a90acf50 | 2024-12-31 | Warnings, Adverse reactions | 209743 ANDA209743 |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | b817083c-b535-2269-e053-2a95a90af5b9 | 2024-12-31 | Warnings, Adverse reactions | 209743 ANDA209743 |
| Pregabalin | PREGABALIN | Proficient Rx LP | a17f03ea-9375-48fe-be32-f8df509f5fba | 2023-06-01 | Warnings, Adverse reactions | 209743 ANDA209743 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-2571-1 | 70518257101 | 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-2571-1) | 60 capsule | 2021-12-09 | 0000-00-00 | No | No | Current |