Gabapentin
- Product NDC
- 83008-049
- 11-digit product format
- 830080049
- Labeler code
- 83008
- Product ID
- 83008-049_d90e8e46-4db4-4761-a13d-e22266fba7a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA204989
- Marketing category
- ANDA
- Marketing start
- 2023-12-21
- Marketing end
- 2026-07-31
- Substance
- GABAPENTIN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6CW7F3G59X | GABAPENTIN | 60142-96-3 | GABAPENTIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 83008-049-60 | 83008004960 | 60 CAPSULE in 1 BOTTLE, PLASTIC (83008-049-60) | 60 capsule | 2023-12-21 | 2026-07-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gabapentin | Quality Care Products, LLC | 2024-12-19 | HUMAN PRESCRIPTION DRUG LABEL | 4 |