Gabapentin
- Product NDC
- 16714-503
- 11-digit product format
- 167140503
- Labeler code
- 16714
- Product ID
- 16714-503_ed396f00-8325-4966-905b-bf5dd69e8284
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA090858
- Marketing category
- ANDA
- Marketing start
- 2016-05-06
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 100 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 product | product | 16714-503 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 16714-503 | 16714-503-01 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 16714-503 | 16714-503-02 | D | Discontinued by firm | 2026-08-03 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 16714-503-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 16714-503-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 16714-503-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 16714-503-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 16714-503-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 16714-503-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 16714-503-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 16714-503-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 16714-503-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 16714-503-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 16714-503-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 16714-503-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 16714-503-02 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 16714-503-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 16714-503-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 16714-503-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 16714-503-02 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 16714-503-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 16714-503-02 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 16714-503-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 16714-503-02 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 16714-503-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 16714-503-02 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 16714-503-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090858-001 | GABAPENTIN | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | |
| A090858-002 | GABAPENTIN | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | |
| A090858-003 | GABAPENTIN | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090858-001 | AB |
| A090858-002 | AB |
| A090858-003 | 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 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090858-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090858-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090858-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090858-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090858-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090858-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090858-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090858-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090858-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090858-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090858-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16714-503-01 | EA - Each | 16714-503 | f6c0d552-9388-45ef-b32e-51eb0bf606da | 1 | 2016-09-02 |
| 16714-503-02 | EA - Each | 16714-503 | 1a897e7c-4793-47ec-827b-cd82a1ba447a | 1 | 2016-09-02 |
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 |
|---|---|---|---|---|---|---|
| Gabapentin | GABAPENTIN | Ascend Laboratories, LLC | 722de2a9-38b3-4518-b262-ba0d1346d0ba | 2026-07-24 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | a1006139-7dfc-4d87-a5a9-aeb380c32d24 | 2026-07-15 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | 896c7782-1137-454b-aaa6-28f42c7413ef | 2026-07-15 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 6a0a75ac-e121-477b-a9d1-d11f588afc9d | 2026-07-14 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | 7652adc6-1aad-4422-b85c-0c6b11c23b73 | 2026-07-14 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | d06380d0-c894-427e-b13e-5a8f9eb86a34 | 2026-07-10 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | 78445dbf-c7cd-419f-a7be-72821e496628 | 2026-07-06 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Major Pharmaceuticals | 36f74fdf-0dae-47a0-a7ea-e64ac91cd88f | 2026-07-02 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | HAWAII REPACK, INC. | 14d61caa-17ce-4fa2-90fb-1470f3864be8 | 2026-06-26 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Northwind Health Company, LLC | 552912b2-be59-0333-e063-6394a90a85c0 | 2026-06-25 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Northwind Health Company, LLC | 55292235-bf8f-46d0-e063-6294a90a91a5 | 2026-06-25 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | 3e633cd0-5ee8-4a05-bcfc-0a80209bf27f | 2026-06-24 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Unit Dose Solutions, Inc. | 54ecc64b-f019-9fcb-e063-6294a90a00af | 2026-06-23 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | ddb3a54f-5224-4024-8804-b2a2f01d885e | 2026-06-22 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Cardinal Health 107, LLC | 41844c21-9e2a-4332-a8ff-9b71ae9032b0 | 2026-06-18 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | 03031adf-d36b-45ec-944e-dfce5a5de91a | 2026-05-28 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Cardinal Health 107, LLC | d4f21e97-5e55-44c9-9b31-5f79ac2eb512 | 2026-05-18 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Major Pharmaceuticals | 999f3685-2eac-467e-bed2-1d0c36aaf0ed | 2026-05-04 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | fce0c123-29d7-42bf-8c8d-8be1772e2d99 | 2026-04-24 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Advanced Rx of Tennessee, LLC | afc83432-8fce-6d2a-e053-2a95a90ae73f | 2026-03-19 | Warnings, Adverse reactions | 090858 ANDA090858 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16714-503-01 | 16714050301 | 100 CAPSULE in 1 BOTTLE (16714-503-01) | 100 capsule | 2016-05-06 | 0000-00-00 | No | No | Current |
| 16714-503-02 | 16714050302 | 500 CAPSULE in 1 BOTTLE (16714-503-02) | 500 capsule | 2016-05-06 | 0000-00-00 | No | No | Current |