PREGABALIN
- Product NDC
- 72205-079
- 11-digit product format
- 722050079
- Labeler code
- 72205
- Product ID
- 72205-079_f6aa5977-97c8-4a56-8e35-d9ab5cc24369
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA213226
- Marketing category
- ANDA
- Marketing start
- 2021-04-13
- Substance
- PREGABALIN
- Active strength
- 330 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 | 330 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 1988974, 1988977, 1988980 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72205-079-30 | PREGABALIN | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72205-079 | PREGABALIN TABLET, FILM COATED, EXTENDED RELEASE [NOVADOZ PHARMACEUTICALS LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20210418_f6aa5977-97c8-4a56-8e35-d9ab5cc24369.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72205-079-30 | 72205007930 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-079-30) | 2021-04-13 | 0000-00-00 | No | No | Current |