PREGABALIN
- Product NDC
- 0904-6992
- 11-digit product format
- 009046992
- Labeler code
- 0904
- Product ID
- 0904-6992_ce6f3554-3f28-4d2e-8f32-e0893f1f43a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA210432
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Substance
- PREGABALIN
- Active strength
- 50 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PREGABALIN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREGABALIN | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6992-61 | PREGABALIN | 100 in 1 CARTON | CAPSULE | 100 | | 7 |
| 0904-6992-61 | PREGABALIN | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6992 | PREGABALIN CAPSULE [MAJOR PHARMACEUTICALS] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250206_2420e2d7-c01a-4590-88c5-6fe5361747e9.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 |
|---|
| 0904-6992-61 | 00904699261 | 100 BLISTER PACK in 1 CARTON (0904-6992-61) / 1 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2019-07-19 | 0000-00-00 | No | No | Current |