Gabapentin
- Product NDC
- 80425-0097
- 11-digit product format
- 804250097
- Labeler code
- 80425
- Product ID
- 80425-0097_2a998d83-7bad-3f5e-e063-6294a90acd3d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA200651
- Marketing category
- ANDA
- Marketing start
- 2011-10-06
- Substance
- GABAPENTIN
- Active strength
- 600 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gabapentin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GABAPENTIN | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310433 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0097-1 | Gabapentin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
| 80425-0097-2 | Gabapentin | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 9 |
| 80425-0097-3 | Gabapentin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 9 |
| 80425-0097-4 | Gabapentin | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0097 | GABAPENTIN TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250101_b37b1dcc-c7e9-8845-e053-2995a90a089e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 80425-0097-1 | 80425009701 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0097-1) | 2011-10-06 | 0000-00-00 | No | No | Current |
| 80425-0097-2 | 80425009702 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0097-2) | 2011-10-06 | 0000-00-00 | No | No | Current |
| 80425-0097-3 | 80425009703 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0097-3) | 2011-10-06 | 0000-00-00 | No | No | Current |
| 80425-0097-4 | 80425009704 | 120 TABLET, FILM COATED in 1 BOTTLE (80425-0097-4) | 2011-10-06 | 0000-00-00 | No | No | Current |