Pregabalin
- Product NDC
- 67877-457
- 11-digit product format
- 678770457
- Labeler code
- 67877
- Product ID
- 67877-457_59a80208-5cc1-476c-a24b-296bc68e1e0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA207623
- Marketing category
- ANDA
- Marketing start
- 2019-07-21
- 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 |
|---|
| 67877-457-47 | Pregabalin | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-457 | PREGABALIN SOLUTION [ASCEND LABORATORIES, LLC] | 15 | Current NDC, Legacy NDC, 1 package rows | 20231214_1b731dd5-b000-4c38-bfc8-2505b076e316.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 |
|---|
| 67877-457-47 | 67877045747 | 473 mL in 1 BOTTLE (67877-457-47) | 473 ml | 2019-07-21 | 0000-00-00 | No | No | Current |