Pregabalin
- Product NDC
- 62332-119
- 11-digit product format
- 623320119
- Labeler code
- 62332
- Product ID
- 62332-119_1e87ec6d-6f2d-400f-bf21-08fcce28bb6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA203459
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Substance
- PREGABALIN
- Active strength
- 25 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 | 25 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 |
|---|
| 62332-119-10 | Pregabalin | 100 in 1 CARTON | CAPSULE | 100 | | 14 |
| 62332-119-30 | Pregabalin | 30 in 1 BOTTLE | CAPSULE | 30 | | 14 |
| 62332-119-90 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | | 14 |
| 62332-119-91 | Pregabalin | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-119 | PREGABALIN CAPSULE [ALEMBIC PHARMACEUTICALS INC.] | 12 | Current NDC, Legacy NDC, 4 package rows | 20240314_cf7b4b67-b017-47ac-af3f-bde5bd07bb0c.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 |
|---|
| 62332-119-10 | 62332011910 | 100 CAPSULE in 1 CARTON (62332-119-10) | 100 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |
| 62332-119-30 | 62332011930 | 30 CAPSULE in 1 BOTTLE (62332-119-30) | 30 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |
| 62332-119-90 | 62332011990 | 90 CAPSULE in 1 BOTTLE (62332-119-90) | 90 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |
| 62332-119-91 | 62332011991 | 1000 CAPSULE in 1 BOTTLE (62332-119-91) | 1000 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |