GABAPENTIN
- Product NDC
- 71610-621
- 11-digit product format
- 716100621
- Labeler code
- 71610
- Product ID
- 71610-621_bc931d95-28ae-405b-ad93-e1fe0b51eab9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA214957
- Marketing category
- ANDA
- Marketing start
- 2021-10-01
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- GABAPENTIN
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| GABAPENTIN | 600 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310433 |
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 |
|---|
| 71610-621-15 | 71610062115 | 15 TABLET in 1 BOTTLE (71610-621-15) | 15 tablet | 2022-01-24 | 0000-00-00 | No | No | Current |
| 71610-621-30 | 71610062130 | 30 TABLET in 1 BOTTLE (71610-621-30) | 30 tablet | 2021-12-02 | 0000-00-00 | No | No | Current |
| 71610-621-45 | 71610062145 | 45 TABLET in 1 BOTTLE (71610-621-45) | 45 tablet | 2021-12-02 | 0000-00-00 | No | No | Current |
| 71610-621-53 | 71610062153 | 60 TABLET in 1 BOTTLE (71610-621-53) | 60 tablet | 2022-01-24 | 0000-00-00 | No | No | Current |
| 71610-621-60 | 71610062160 | 90 TABLET in 1 BOTTLE (71610-621-60) | 90 tablet | 2021-12-02 | 0000-00-00 | No | No | Current |
| 71610-621-70 | 71610062170 | 120 TABLET in 1 BOTTLE (71610-621-70) | 120 tablet | 2022-01-24 | 0000-00-00 | No | No | Current |
| 71610-621-73 | 71610062173 | 135 TABLET in 1 BOTTLE (71610-621-73) | 135 tablet | 2021-12-02 | 0000-00-00 | No | No | Current |
| 71610-621-80 | 71610062180 | 180 TABLET in 1 BOTTLE (71610-621-80) | 180 tablet | 2021-12-17 | 0000-00-00 | No | No | Current |
| 71610-621-92 | 71610062192 | 270 TABLET in 1 BOTTLE (71610-621-92) | 270 tablet | 2021-12-02 | 0000-00-00 | No | No | Current |
| 71610-621-94 | 71610062194 | 360 TABLET in 1 BOTTLE (71610-621-94) | 360 tablet | 2022-01-24 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 2022-02-28 | HUMAN PRESCRIPTION DRUG LABEL | 2 |