gabapentin
- Product NDC
- 68382-608
- 11-digit product format
- 683820608
- Labeler code
- 68382
- Product ID
- 68382-608_898c1710-d86c-4fbe-9a53-34661fcdb63a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA203934
- Marketing category
- ANDA
- Marketing start
- 2024-01-25
- Substance
- GABAPENTIN
- Active strength
- 300 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 | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 1806380, 1806382, 2634743, 2634747, 2634751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-608-05 | gabapentin | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
| 68382-608-16 | gabapentin | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
| 68382-608-30 | gabapentin | 10 in 1 BLISTER PACK | TABLET | 10 | | 3 |
| 68382-608-77 | gabapentin | 10 in 1 CARTON | TABLET | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-608 | GABAPENTIN TABLET [ZYDUS PHARMACEUTICALS USA INC.] | 2 | Current NDC, 4 package rows | 20250510_3cfd04ab-e421-441f-a10e-e4dd1412974d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68382-608-05 | 68382060805 | 500 TABLET in 1 BOTTLE (68382-608-05) | 500 tablet | 2024-01-25 | No | No | Current |
| 68382-608-16 | 68382060816 | 90 TABLET in 1 BOTTLE (68382-608-16) | 90 tablet | 2024-01-25 | No | No | Current |
| 68382-608-30 | 68382060830 | 10 in 1 BLISTER PACK | | | | | Historical |
| 68382-608-77 | 68382060877 | 10 BLISTER PACK in 1 CARTON (68382-608-77) / 10 TABLET in 1 BLISTER PACK (68382-608-30) | 10 blister pack | 2024-01-25 | No | No | Current |