Gabapentin
- Product NDC
- 53002-3423
- 11-digit product format
- 530023423
- Labeler code
- 53002
- Product ID
- 53002-3423_c106dd29-d11a-4299-ad56-695b61129c7a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA075350
- Marketing category
- ANDA
- Marketing start
- 2014-04-03
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 53002-3423-0 | 53002342300 | 100 CAPSULE in 1 BOTTLE (53002-3423-0) | 100 capsule | 2020-01-01 | 0000-00-00 | No | No | Current |
| 53002-3423-3 | 53002342303 | 30 CAPSULE in 1 BOTTLE (53002-3423-3) | 30 capsule | 2020-01-01 | 0000-00-00 | No | No | Current |
| 53002-3423-6 | 53002342306 | 60 CAPSULE in 1 BOTTLE (53002-3423-6) | 60 capsule | 2020-01-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gabapentin | RPK Pharmaceuticals, Inc. | 2023-06-07 | HUMAN PRESCRIPTION DRUG LABEL | 3 |