Gabapentin
- Product NDC
- 80425-0035
- 11-digit product format
- 804250035
- Labeler code
- 80425
- Product ID
- 80425-0035_2a984dd9-729b-77f0-e063-6294a90a8f1e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA206402
- Marketing category
- ANDA
- Marketing start
- 2015-11-01
- Substance
- GABAPENTIN
- Active strength
- 800 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 | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310434 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0035-1 | Gabapentin | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0035 | GABAPENTIN TABLET [ADVANCED RX OF TENNESSEE, LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250101_afa28969-91ca-83fd-e053-2a95a90a656b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 80425-0035-1 | 80425003501 | 30 TABLET in 1 BOTTLE (80425-0035-1) | 30 tablet | 2015-11-01 | 0000-00-00 | No | No | Current |