Pregabalin
- Product NDC
- 80425-0030
- 11-digit product format
- 804250030
- Labeler code
- 80425
- Product ID
- 80425-0030_43ccc5cb-7aee-4ee0-e063-6294a90af140
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA209357
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Substance
- PREGABALIN
- Active strength
- 75 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 | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483450 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0030-1 | Pregabalin | 60 in 1 BOTTLE | CAPSULE | 60 | | 7 |
| 80425-0030-2 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0030 | PREGABALIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250101_afc89689-bea9-92ec-e053-2995a90a7f21.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 |
|---|
| 80425-0030-1 | 80425003001 | 60 CAPSULE in 1 BOTTLE (80425-0030-1) | 60 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |
| 80425-0030-2 | 80425003002 | 90 CAPSULE in 1 BOTTLE (80425-0030-2) | 90 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |