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
openFDA Listing Details
- Product ID
- 50228-524_3f2e32c6-5993-0189-e063-6294a90a0ff6
- SPL ID
- 3f2e32c6-5993-0189-e063-6294a90a0ff6
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- gabapentin
- Generic name
- gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2025-09-20
- Marketing category
- ANDA
- Application number
- ANDA218491
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| GABAPENTIN | 600 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 1806380, 1806382 |
| Spl Set Id | 3f2e3ac5-5233-fd57-e063-6294a90a849e |
| Manufacturer Name | ScieGen Pharmaceuticals, Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 50228-524-05 | 500 TABLET in 1 BOTTLE (50228-524-05) | 2025-09-20 | No |
| 50228-524-30 | 30 TABLET in 1 BOTTLE (50228-524-30) | 2025-09-20 | No |
| 50228-524-90 | 90 TABLET in 1 BOTTLE (50228-524-90) | 2025-09-20 | No |
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 |
|---|
| 50228-524-05 | 50228052405 | 500 TABLET in 1 BOTTLE (50228-524-05) | 500 tablet | 2025-09-20 | No | No | Historical |
| 50228-524-30 | 50228052430 | 30 TABLET in 1 BOTTLE (50228-524-30) | 30 tablet | 2025-09-20 | No | No | Historical |
| 50228-524-90 | 50228052490 | 90 TABLET in 1 BOTTLE (50228-524-90) | 90 tablet | 2025-09-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| gabapentin | ScieGen Pharmaceuticals, Inc. | 2025-07-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |