Gabapentin
- Product NDC
- 71610-044
- 11-digit product format
- 716100044
- Labeler code
- 71610
- Product ID
- 71610-044_a695e055-6531-4b51-969f-62165d703511
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA203244
- Marketing category
- ANDA
- Marketing start
- 2014-01-11
- Substance
- GABAPENTIN
- Active strength
- 600 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-044-30 | 71610004430 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-044-30) | 2020-06-10 | No | No | Historical |
| 71610-044-45 | 71610004445 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-044-45) | 2020-06-10 | No | No | Historical |
| 71610-044-53 | 71610004453 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-044-53) | 2020-06-10 | No | No | Historical |
| 71610-044-60 | 71610004460 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-044-60) | 2018-03-23 | No | No | Historical |
| 71610-044-70 | 71610004470 | 120 TABLET, FILM COATED in 1 BOTTLE (71610-044-70) | 2020-07-30 | No | No | Historical |
| 71610-044-73 | 71610004473 | 135 TABLET, FILM COATED in 1 BOTTLE (71610-044-73) | 2020-07-30 | No | No | Historical |
| 71610-044-80 | 71610004480 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-044-80) | 2018-03-23 | No | No | Historical |
| 71610-044-92 | 71610004492 | 270 TABLET, FILM COATED in 1 BOTTLE (71610-044-92) | 2018-03-23 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | 2020-08-05 | HUMAN PRESCRIPTION DRUG LABEL | 3 |