Gabapentin
- Product NDC
- 76420-235
- 11-digit product format
- 764200235
- Labeler code
- 76420
- Product ID
- 76420-235_e347fcb2-dba9-193d-e053-2995a90a4784
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA205101
- Marketing category
- ANDA
- Marketing start
- 2016-02-04
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-235-12 | 76420023512 | 120 TABLET in 1 BOTTLE (76420-235-12) | 120 tablet | 2022-07-07 | No | No | Historical |
| 76420-235-24 | 76420023524 | 240 TABLET in 1 BOTTLE (76420-235-24) | 240 tablet | 2022-07-07 | No | No | Historical |
| 76420-235-30 | 76420023530 | 30 TABLET in 1 BOTTLE (76420-235-30) | 30 tablet | 2022-07-07 | No | No | Historical |
| 76420-235-60 | 76420023560 | 60 TABLET in 1 BOTTLE (76420-235-60) | 60 tablet | 2022-07-07 | No | No | Historical |
| 76420-235-90 | 76420023590 | 90 TABLET in 1 BOTTLE (76420-235-90) | 90 tablet | 2022-07-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gabapentin | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2022-07-07 | HUMAN PRESCRIPTION DRUG LABEL | 1 |