Pregabalin
- Product NDC
- 59762-1576
- 11-digit product format
- 597621576
- Labeler code
- 59762
- Product ID
- 59762-1576_7aa334e7-3c46-4680-a266-9049af3bf566
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA022488
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-07-29
- Substance
- PREGABALIN
- Active strength
- 20 mg/mL
- 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 | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 898715 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59762-1576-1 | Pregabalin | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 13 |
| 59762-1576-1 | Pregabalin | 1 in 1 CARTON | SOLUTION | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59762-1576 | PREGABALIN CAPSULE PREGABALIN SOLUTION [MYLAN PHARMACEUTICALS INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20250503_ebe34db4-816d-4f0a-adbb-826693662754.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 |
|---|
| 59762-1576-1 | 59762157601 | 1 BOTTLE in 1 CARTON (59762-1576-1) / 473 mL in 1 BOTTLE | 1 bottle | 2019-07-29 | 0000-00-00 | No | No | Current |