Gabapentin
- Product NDC
- 69292-642
- 11-digit product format
- 692920642
- Labeler code
- 69292
- Product ID
- 69292-642_49d67ffb-5d4f-486e-8766-cf56faf70ede
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amici Pharma, Inc.
- Application
- ANDA219319
- Marketing category
- ANDA
- Marketing start
- 2026-05-15
- Substance
- GABAPENTIN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 | Sample | Exclude flag | Status |
|---|
| 69292-642-01 | 69292064201 | 100 CAPSULE in 1 BOTTLE (69292-642-01) | 100 capsule | 2026-05-15 | No | No | Historical |
| 69292-642-10 | 69292064210 | 1000 CAPSULE in 1 BOTTLE (69292-642-10) | 1000 capsule | 2026-05-15 | No | No | Historical |
| 69292-642-50 | 69292064250 | 500 CAPSULE in 1 BOTTLE (69292-642-50) | 500 capsule | 2026-05-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gabapentin | Amici Pharma, Inc. | Stallion laboratories Pvt. Ltd. | 2026-05-19 | HUMAN PRESCRIPTION DRUG LABEL | 2 |