Gabapentin
- Product NDC
- 71610-631
- 11-digit product format
- 716100631
- Labeler code
- 71610
- Product ID
- 71610-631_2b5aee3a-519c-0872-e063-6294a90a1bb9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA204989
- Marketing category
- ANDA
- Marketing start
- 2016-02-18
- Substance
- GABAPENTIN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71610-631_2b5aee3a-519c-0872-e063-6294a90a1bb9
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Gabapentin
- Generic name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing start
- 2016-02-18
- Marketing category
- ANDA
- Application number
- ANDA204989
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| GABAPENTIN | 400 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310432 |
| Spl Set Id | 95757436-2093-41cf-a9a9-ef2f28ac096f |
| Manufacturer Name | Aphena Pharma Solutions - Tennessee, LLC |
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 |
|---|
| 71610-631-53 | 71610063153 | 60 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-53) | 60 capsule | 2022-01-31 | 0000-00-00 | No | No | Current |
| 71610-631-60 | 71610063160 | 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-60) | 90 capsule | 2022-01-31 | 0000-00-00 | No | No | Current |
| 71610-631-80 | 71610063180 | 180 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-80) | 180 capsule | 2022-01-31 | 0000-00-00 | No | No | Current |
| 71610-631-92 | 71610063192 | 270 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-92) | 270 capsule | 2022-01-31 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | 2025-01-09 | HUMAN PRESCRIPTION DRUG LABEL | 2 |