gabapentin
- Product NDC
- 50228-524
- 11-digit product format
- 502280524
- Labeler code
- 50228
- Product ID
- 50228-524_3f2e32c6-5993-0189-e063-6294a90a0ff6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc.
- Application
- ANDA218491
- Marketing category
- ANDA
- Marketing start
- 2025-09-20
- 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 | 1806380, 1806382 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-524-05 | gabapentin | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
| 50228-524-30 | gabapentin | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 50228-524-90 | gabapentin | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50228-524-05 | 50228052405 | 500 TABLET in 1 BOTTLE (50228-524-05) | 500 tablet | 2025-09-20 | No | No | Current |
| 50228-524-30 | 50228052430 | 30 TABLET in 1 BOTTLE (50228-524-30) | 30 tablet | 2025-09-20 | No | No | Current |
| 50228-524-90 | 50228052490 | 90 TABLET in 1 BOTTLE (50228-524-90) | 90 tablet | 2025-09-20 | No | No | Current |