Pregabalin
- Product NDC
- 71610-936
- 11-digit product format
- 716100936
- Labeler code
- 71610
- Product ID
- 71610-936_3c6d5d78-6f10-a921-e063-6294a90a3f9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA208677
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- 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 |
|---|
| 71610-936-30 | Pregabalin | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 71610-936-46 | Pregabalin | 56 in 1 BOTTLE | CAPSULE | 56 | | 1 |
| 71610-936-53 | Pregabalin | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
| 71610-936-92 | Pregabalin | 270 in 1 BOTTLE | CAPSULE | 270 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-936-30 | 71610093630 | 30 CAPSULE in 1 BOTTLE (71610-936-30) | 30 capsule | 2025-08-15 | No | No | Historical |
| 71610-936-46 | 71610093646 | 56 CAPSULE in 1 BOTTLE (71610-936-46) | 56 capsule | 2025-08-15 | No | No | Historical |
| 71610-936-53 | 71610093653 | 60 CAPSULE in 1 BOTTLE (71610-936-53) | 60 capsule | 2025-08-15 | No | No | Historical |
| 71610-936-92 | 71610093692 | 270 CAPSULE in 1 BOTTLE (71610-936-92) | 270 capsule | 2025-08-15 | No | No | Historical |