Neurontin
- Product NDC
- 0071-0806
- Requested package NDC
- 0071-0806-24
- 11-digit product format
- 000710806
- Labeler code
- 0071
- Product ID
- 0071-0806_20876c74-5c0b-472c-a19a-d79987402df2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Parke-Davis Div of Pfizer Inc
- Application
- NDA020235
- Marketing category
- NDA
- Marketing start
- 1993-12-30
- 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
- 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 | 0071-0806 | 0071-0806-24 | D | Discontinued by firm | 2026-10-05 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020235-001 | NEURONTIN | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 |
| N020235-002 | NEURONTIN | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 |
| N020235-003 | NEURONTIN | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | RLD, RS | 1993-12-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020235-001 | AB |
| N020235-002 | AB |
| N020235-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020235-001 | NEURONTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020235-002 | NEURONTIN | 300MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020235-003 | NEURONTIN | 400MG | CAPSULE / ORAL | AB | RLD, RS | 1993-12-30 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N020235-001 | NEURONTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020235-002 | NEURONTIN | 300MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020235-003 | NEURONTIN | 400MG | CAPSULE / ORAL | AB | RLD, RS | 1993-12-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020235-001 | NEURONTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020235-002 | NEURONTIN | 300MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020235-003 | NEURONTIN | 400MG | CAPSULE / ORAL | AB | RLD, RS | 1993-12-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020235-001 | NEURONTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020235-002 | NEURONTIN | 300MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020235-003 | NEURONTIN | 400MG | CAPSULE / ORAL | AB | RLD, RS | 1993-12-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020235-001 | NEURONTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020235-002 | NEURONTIN | 300MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020235-003 | NEURONTIN | 400MG | CAPSULE / ORAL | AB | RLD, RS | 1993-12-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020235-001 | NEURONTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020235-002 | NEURONTIN | 300MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020235-003 | NEURONTIN | 400MG | CAPSULE / ORAL | AB | RLD, RS | 1993-12-30 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020235-001 | NEURONTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020235-002 | NEURONTIN | 300MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020235-003 | NEURONTIN | 400MG | CAPSULE / ORAL | AB | RLD, RS | 1993-12-30 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020235-001 | NEURONTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020235-002 | NEURONTIN | 300MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020235-003 | NEURONTIN | 400MG | CAPSULE / ORAL | AB | RLD, RS | 1993-12-30 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020235-001 | NEURONTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020235-002 | NEURONTIN | 300MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020235-003 | NEURONTIN | 400MG | CAPSULE / ORAL | AB | RLD, RS | 1993-12-30 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020235-001 | NEURONTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020235-002 | NEURONTIN | 300MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020235-003 | NEURONTIN | 400MG | CAPSULE / ORAL | AB | RLD, RS | 1993-12-30 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020235-001 | NEURONTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020235-002 | NEURONTIN | 300MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020235-003 | NEURONTIN | 400MG | CAPSULE / ORAL | AB | RLD, RS | 1993-12-30 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020235-001 | NEURONTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020235-002 | NEURONTIN | 300MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020235-003 | NEURONTIN | 400MG | CAPSULE / ORAL | AB | RLD, RS | 1993-12-30 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020235-001 | NEURONTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020235-002 | NEURONTIN | 300MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020235-003 | NEURONTIN | 400MG | CAPSULE / ORAL | AB | RLD, RS | 1993-12-30 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020235-001 | NEURONTIN | 100MG | CAPSULE / ORAL | AB | RLD | 1993-12-30 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020235-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020235-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020235-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N020235-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020235-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020235-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020235-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020235-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020235-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020235-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020235-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020235-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020235-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020235-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020235-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020235-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020235-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020235-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020235-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020235-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020235-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020235-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020235-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020235-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020235-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020235-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020235-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020235-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020235-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020235-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020235-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020235-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020235-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020235-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020235-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020235-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020235-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020235-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020235-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020235-001 | AB | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cdc2ae60-922e-452d-a42f-787fe4e2ed06 | Product name | 1 | 20250123 |
| 7059096a-4b9f-36c2-db50-bb5c723e6e9e | Product name | 2 | 20250114 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0071-0806-24 | Neurontin | 100 in 1 BOTTLE | CAPSULE | 100 | 47 | |
| 0071-0806-40 | Neurontin | 50 in 1 CARTON | CAPSULE | 50 | 47 | |
| 0071-0806-40 | Neurontin | 1 in 1 BLISTER PACK | CAPSULE | 1 | 47 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0071-0806-24 | EA - Each | 0071-0806 | 1a2db6c4-a078-4225-bfde-843508c09e79 | 1 | 2012-07-24 |
| 0071-0806-40 | EA - Each | 0071-0806 | c0394147-5f31-430f-bf9f-2737c05571d2 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0071-0806 | NEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC] | 42 | Legacy NDC, 3 package rows | 20241009_ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388.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 |
|---|---|---|---|---|---|---|
| Neurontin | GABAPENTIN | Viatris Specialty LLC | 97935fd9-1d4a-43b6-a5d9-de994591187b | 2026-05-12 | Warnings, Adverse reactions | 020235 NDA020235 |
| Neurontin | GABAPENTIN | Parke-Davis Div of Pfizer Inc | ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388 | 2022-07-12 | Warnings, Adverse reactions | 020235 NDA020235 0071-0806-24 0071-0806 00071080624 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0071-0806-24 | 00071080624 | 100 CAPSULE in 1 BOTTLE (0071-0806-24) | 100 capsule | 1993-12-30 | 0000-00-00 | No | No | Current |