Gabapentin
- Product NDC
- 76420-497
- 11-digit product format
- 764200497
- Labeler code
- 76420
- Product ID
- 76420-497_eaa81374-5d2c-60d1-e053-2a95a90af8ea
- 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
- 800 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 |
|---|
| 76420-497-01 | 76420049701 | 100 TABLET in 1 BOTTLE (76420-497-01) | 100 tablet | 2022-10-10 | No | No | Historical |
| 76420-497-05 | 76420049705 | 500 TABLET in 1 BOTTLE (76420-497-05) | 500 tablet | 2022-10-10 | No | No | Historical |
| 76420-497-12 | 76420049712 | 120 TABLET in 1 BOTTLE (76420-497-12) | 120 tablet | 2022-10-10 | No | No | Historical |
| 76420-497-24 | 76420049724 | 240 TABLET in 1 BOTTLE (76420-497-24) | 240 tablet | 2022-10-10 | No | No | Historical |
| 76420-497-30 | 76420049730 | 30 TABLET in 1 BOTTLE (76420-497-30) | 30 tablet | 2022-10-10 | No | No | Historical |
| 76420-497-60 | 76420049760 | 60 TABLET in 1 BOTTLE (76420-497-60) | 60 tablet | 2022-10-10 | No | No | Historical |
| 76420-497-90 | 76420049790 | 90 TABLET in 1 BOTTLE (76420-497-90) | 90 tablet | 2022-10-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gabapentin | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2022-10-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |