Gabapentin
- Product NDC
- 63187-031
- 11-digit product format
- 631870031
- Labeler code
- 63187
- Product ID
- 63187-031_75599dc3-b3a3-440f-b052-6e980c297c93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA090705
- Marketing category
- ANDA
- Marketing start
- 2010-05-17
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 300 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
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63187-031-00 | EA - Each | 63187-031 | 71d4bbe9-5ccb-44e5-9b8b-58f7c2a2170b | 1 | 2016-04-04 |
| 63187-031-30 | EA - Each | 63187-031 | 5d721d69-9289-454e-b50b-ca2e06fd3a9a | 1 | 2016-06-14 |
| 63187-031-60 | EA - Each | 63187-031 | 5af27e42-e503-480c-b933-f4c54ae814ee | 1 | 2015-10-02 |
| 63187-031-90 | EA - Each | 63187-031 | add38d46-48cc-4721-b33e-5cd5792d185d | 1 | 2015-05-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN CAPSULE [PROFICIENT RX LP] | 7 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN CAPSULE [PROFICIENT RX LP] | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | GABAPENTIN CAPSULE [PROFICIENT RX LP] | 7 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | GABAPENTIN CAPSULE [PROFICIENT RX LP] | 7 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | GABAPENTIN CAPSULE [PROFICIENT RX LP] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GABAPENTIN CAPSULE [PROFICIENT RX LP] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN CAPSULE [PROFICIENT RX LP] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GABAPENTIN CAPSULE [PROFICIENT RX LP] | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63187-031-00 | 63187003100 | 100 CAPSULE in 1 BOTTLE (63187-031-00) | 100 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-031-30 | 63187003130 | 30 CAPSULE in 1 BOTTLE (63187-031-30) | 30 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-031-60 | 63187003160 | 60 CAPSULE in 1 BOTTLE (63187-031-60) | 60 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-031-72 | 63187003172 | 120 CAPSULE in 1 BOTTLE (63187-031-72) | 120 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-031-90 | 63187003190 | 90 CAPSULE in 1 BOTTLE (63187-031-90) | 90 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |