Pregabalin
- Product NDC
- 46708-121
- 11-digit product format
- 467080121
- Labeler code
- 46708
- Product ID
- 46708-121_b746d2ae-57e4-4a36-9524-35c4aa6b4ef2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA203459
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Substance
- PREGABALIN
- Active strength
- 75 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pregabalin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREGABALIN | 75 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 |
|---|
| 46708-121-10 | Pregabalin | 100 in 1 CARTON | CAPSULE | 100 | | 4 |
| 46708-121-30 | Pregabalin | 30 in 1 BOTTLE | CAPSULE | 30 | | 4 |
| 46708-121-90 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | | 4 |
| 46708-121-91 | Pregabalin | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-121 | PREGABALIN CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] | 4 | Current NDC, Legacy NDC, 4 package rows | 20230513_78a36538-701d-4dd9-a7fc-87d505784c83.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 |
|---|
| 46708-121-10 | 46708012110 | 100 CAPSULE in 1 CARTON (46708-121-10) | 100 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |
| 46708-121-30 | 46708012130 | 30 CAPSULE in 1 BOTTLE (46708-121-30) | 30 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |
| 46708-121-90 | 46708012190 | 90 CAPSULE in 1 BOTTLE (46708-121-90) | 90 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |
| 46708-121-91 | 46708012191 | 1000 CAPSULE in 1 BOTTLE (46708-121-91) | 1000 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |