GABAPENTIN
- Product NDC
- 43063-758
- 11-digit product format
- 430630758
- Labeler code
- 43063
- Product ID
- 43063-758_d2bb8d09-196f-963a-e053-2a95a90a430c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA204989
- Marketing category
- ANDA
- Marketing start
- 2016-09-30
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 43063-758 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 43063-758 | 43063-758-30 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 43063-758 | 43063-758-60 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 43063-758 | 43063-758-83 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 43063-758 | 43063-758-86 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 43063-758 | 43063-758-90 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 43063-758 | 43063-758-93 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 43063-758 | 43063-758-94 | D | Discontinued by firm | 2026-10-05 |
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 | 43063-758-93 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43063-758-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43063-758-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43063-758-94 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43063-758-86 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43063-758-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43063-758-83 | 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 | 43063-758-93 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43063-758-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43063-758-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43063-758-94 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43063-758-86 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43063-758-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43063-758-83 | 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 | 43063-758-93 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43063-758-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43063-758-90 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43063-758-94 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43063-758-86 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43063-758-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43063-758-83 | 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 | 43063-758-93 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43063-758-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43063-758-90 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43063-758-94 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43063-758-86 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43063-758-60 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43063-758-83 | 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 | 43063-758-93 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43063-758-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43063-758-90 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43063-758-94 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43063-758-86 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43063-758-60 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43063-758-83 | 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 | 43063-758-93 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43063-758-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43063-758-90 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43063-758-94 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43063-758-86 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43063-758-60 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43063-758-83 | 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 | 43063-758-93 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43063-758-30 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43063-758-90 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43063-758-94 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43063-758-86 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43063-758-60 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43063-758-83 | 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 | 43063-758-93 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 43063-758-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 43063-758-90 | ed331223b511… | 672a5bd82f5f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204989-001 | RELGAABI | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | |
| A204989-002 | RELGAABI | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | |
| A204989-003 | RELGAABI | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | |
| A204989-004 | RELGAABI | GABAPENTIN | 200MG | CAPSULE / ORAL | AB | 2026-03-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204989-001 | AB |
| A204989-002 | AB |
| A204989-003 | AB |
| A204989-004 | 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 | A204989-001 | RELGAABI | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204989-002 | RELGAABI | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204989-003 | RELGAABI | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204989-004 | RELGAABI | 200MG | CAPSULE / ORAL | AB | 2026-03-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A204989-001 | RELGAABI | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204989-002 | RELGAABI | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204989-003 | RELGAABI | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204989-004 | RELGAABI | 200MG | CAPSULE / ORAL | AB | 2026-03-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204989-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204989-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204989-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204989-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A204989-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204989-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204989-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204989-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204989-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204989-002 | AB | 1 | 79d66fd596c7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43063-758-30 | EA - Each | 43063-758 | f3f21ad4-b76c-4adf-bb8f-bb759cfd0e2d | 1 | 2017-06-15 |
| 43063-758-60 | EA - Each | 43063-758 | ac324784-de41-42a6-bab7-e4acd8c74e32 | 1 | 2017-06-15 |
| 43063-758-83 | EA - Each | 43063-758 | dad38c47-e698-472f-ba8d-371f4c9c5d5a | 1 | 2017-06-15 |
| 43063-758-86 | EA - Each | 43063-758 | 907388a6-dd62-43a1-9f6b-109f0098c794 | 1 | 2017-06-15 |
| 43063-758-90 | EA - Each | 43063-758 | 14cb0857-1039-47d5-8212-a233258ed3ef | 1 | 2017-06-15 |
| 43063-758-93 | EA - Each | 43063-758 | b156c02b-1320-49a5-a00a-ef157fe18f6c | 1 | 2017-06-15 |
| 43063-758-94 | EA - Each | 43063-758 | 5bf3ef4b-027d-4866-a162-644a0a2aa2cb | 1 | 2017-06-15 |
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 | Preferred Pharmaceuticals Inc. | 100ff86c-56a8-4770-9db3-b9bc6b1bd2f7 | 2026-04-30 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals Inc. | e3429322-c442-4146-bb68-bcc3a8d01552 | 2026-04-29 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals Inc. | 2625c0ef-5295-41de-9e81-88001a6cbecc | 2026-04-29 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals, Inc. | 41dcc917-68d1-49f0-8223-44c21ca259ef | 2026-04-29 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Coupler LLC | 5073abda-321f-29d1-e063-6394a90a59ac | 2026-04-27 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | PHOENIX RX LLC | 4f95c01f-200e-bfd7-e063-6394a90abc38 | 2026-04-16 | Warnings, Adverse reactions | 204989 ANDA204989 |
| RELGAABI | GABAPENTIN | Method Pharmaceuticals, LLC | 4cc6615b-5447-9c0e-e063-6394a90a2883 | 2026-04-08 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | 54c09aa5-6724-480a-a115-c88484e39e93 | 2026-02-24 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals, Inc. | bff3beea-1f05-4e84-bcd2-d05782acddae | 2026-01-14 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | 25befbfa-5125-4363-8306-f862e81c0a6f | 2025-10-28 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | 1ead7343-ab25-41b5-af4f-f903470e1dd9 | 2025-10-10 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | 781b0d62-a760-4371-8908-1f61329928a6 | 2025-10-10 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Direct_Rx | ed9cb5fe-7a2e-e0bc-e053-2a95a90a4470 | 2025-01-22 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals Inc. | db57e37f-0a78-4c14-8768-a28bbf9fa0da | 2025-01-21 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals,Inc. | bd5c9279-a1e3-2a59-e053-2a95a90a33a2 | 2025-01-14 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 41ce952c-6c16-4b5d-adf7-9ea114e63eb3 | 2025-01-09 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 13b87441-8fe1-40f5-8ffb-00dcd8cc90a6 | 2025-01-09 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 95757436-2093-41cf-a9a9-ef2f28ac096f | 2025-01-09 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Advanced Rx of Tennessee, LLC | d294f6aa-ed82-90a2-e053-2995a90a2896 | 2024-12-31 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Quality Care Products, LLC | ed3a0d48-2e98-44ee-8743-880d1221a480 | 2024-12-18 | Warnings, Adverse reactions | 204989 ANDA204989 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43063-758-30 | 43063075830 | 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-758-30) | 30 capsule | 2017-04-25 | 0000-00-00 | No | No | Current |
| 43063-758-60 | 43063075860 | 60 CAPSULE in 1 BOTTLE, PLASTIC (43063-758-60) | 60 capsule | 2017-04-25 | 0000-00-00 | No | No | Current |
| 43063-758-83 | 43063075883 | 540 CAPSULE in 1 BOTTLE, PLASTIC (43063-758-83) | 540 capsule | 2017-04-25 | 0000-00-00 | No | No | Current |
| 43063-758-86 | 43063075886 | 360 CAPSULE in 1 BOTTLE, PLASTIC (43063-758-86) | 360 capsule | 2017-04-25 | 0000-00-00 | No | No | Current |
| 43063-758-90 | 43063075890 | 90 CAPSULE in 1 BOTTLE, PLASTIC (43063-758-90) | 90 capsule | 2017-04-25 | 0000-00-00 | No | No | Current |
| 43063-758-93 | 43063075893 | 180 CAPSULE in 1 BOTTLE, PLASTIC (43063-758-93) | 180 capsule | 2017-04-25 | 0000-00-00 | No | No | Current |
| 43063-758-94 | 43063075894 | 270 CAPSULE in 1 BOTTLE, PLASTIC (43063-758-94) | 270 capsule | 2017-04-25 | 0000-00-00 | No | No | Current |