Pregabalin
- Product NDC
- 72888-050
- 11-digit product format
- 728880050
- Labeler code
- 72888
- Product ID
- 72888-050_49fe33c0-b2ae-e0c1-e063-6294a90a36a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Advagen Pharma Ltd.
- Application
- ANDA215249
- Marketing category
- ANDA
- Marketing start
- 2022-03-22
- Substance
- PREGABALIN
- Active strength
- 165 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pregabalin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREGABALIN | 165 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 |
|---|
| 72888-050-30 | Pregabalin | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72888-050 | PREGABALIN TABLET, FILM COATED, EXTENDED RELEASE [ADVAGEN PHARMA LTD.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230504_2ffee7e7-bfa0-4933-9baf-7df55080816e.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 |
|---|
| 72888-050-30 | 72888005030 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72888-050-30) | 2022-03-22 | 0000-00-00 | No | No | Current |