Pregabalin
- Product NDC
- 71610-997
- 11-digit product format
- 716100997
- Labeler code
- 71610
- Product ID
- 71610-997_4ddf529d-462f-2828-e063-6294a90a63bf
- 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
- 2025-12-10
- Substance
- PREGABALIN
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483446 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-997-30 | Pregabalin | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 71610-997-46 | Pregabalin | 56 in 1 BOTTLE | CAPSULE | 56 | | 1 |
| 71610-997-53 | Pregabalin | 60 in 1 BOTTLE | CAPSULE | 60 | | 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 |
|---|
| 71610-997-30 | 71610099730 | 30 CAPSULE in 1 BOTTLE (71610-997-30) | 30 capsule | 2026-03-25 | No | No | Historical |
| 71610-997-46 | 71610099746 | 56 CAPSULE in 1 BOTTLE (71610-997-46) | 56 capsule | 2026-03-25 | No | No | Historical |
| 71610-997-53 | 71610099753 | 60 CAPSULE in 1 BOTTLE (71610-997-53) | 60 capsule | 2026-03-25 | No | No | Historical |