Pregabalin
- Product NDC
- 80425-0170
- 11-digit product format
- 804250170
- Labeler code
- 80425
- Product ID
- 80425-0170_2a99a80e-d071-27e6-e063-6294a90ae0fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA206912
- Marketing category
- ANDA
- Marketing start
- 2019-10-08
- Substance
- PREGABALIN
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483438 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0170-3 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0170 | PREGABALIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250101_c8bfc4f9-6208-4eaa-e053-2a95a90ada97.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 |
|---|
| 80425-0170-3 | 80425017003 | 90 CAPSULE in 1 BOTTLE (80425-0170-3) | 90 capsule | 2019-10-08 | 0000-00-00 | No | No | Current |