GABAPENTIN
- Product NDC
- 71610-757
- 11-digit product format
- 716100757
- Labeler code
- 71610
- Product ID
- 71610-757_9f1cfdaf-a07f-4f37-9f9c-695cafe6cfee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA214956
- Marketing category
- ANDA
- Marketing start
- 2021-05-10
- 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
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 |
|---|
| 71610-757-53 | 71610075753 | 60 CAPSULE in 1 BOTTLE (71610-757-53) | 60 capsule | 2023-11-28 | No | No | Historical |
| 71610-757-60 | 71610075760 | 90 CAPSULE in 1 BOTTLE (71610-757-60) | 90 capsule | 2024-01-03 | No | No | Historical |
| 71610-757-80 | 71610075780 | 180 CAPSULE in 1 BOTTLE (71610-757-80) | 180 capsule | 2023-11-28 | No | No | Historical |
| 71610-757-94 | 71610075794 | 360 CAPSULE in 1 BOTTLE (71610-757-94) | 360 capsule | 2024-01-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 2024-01-04 | HUMAN PRESCRIPTION DRUG LABEL | 6 |