Pregabalin
- Product NDC
- 71610-792
- 11-digit product format
- 716100792
- Labeler code
- 71610
- Product ID
- 71610-792_dcc0966b-b682-4e0f-9938-b13a09bb4701
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA209357
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Substance
- PREGABALIN
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483442 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-792-30 | Pregabalin | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 71610-792-53 | Pregabalin | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-792 | PREGABALIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, 2 package rows | 20240209_4ed3e73c-13e7-4646-874d-276b6c75d2c9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-792-30 | 71610079230 | 30 CAPSULE in 1 BOTTLE (71610-792-30) | 30 capsule | 2024-01-31 | No | No | Current |
| 71610-792-53 | 71610079253 | 60 CAPSULE in 1 BOTTLE (71610-792-53) | 60 capsule | 2024-01-31 | No | No | Current |