Pregabalin
- Product NDC
- 71610-999
- 11-digit product format
- 716100999
- Labeler code
- 71610
- Product ID
- 71610-999_51163e0c-e671-3dc4-e063-6294a90abde9
- 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
- 75 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 | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483450 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-999-30 | 71610099930 | 30 CAPSULE in 1 BOTTLE (71610-999-30) | 30 capsule | 2026-03-25 | No | No | Historical |
| 71610-999-46 | 71610099946 | 56 CAPSULE in 1 BOTTLE (71610-999-46) | 56 capsule | 2026-03-25 | No | No | Historical |
| 71610-999-53 | 71610099953 | 60 CAPSULE in 1 BOTTLE (71610-999-53) | 60 capsule | 2026-03-25 | No | No | Historical |
| 71610-999-70 | 71610099970 | 120 CAPSULE in 1 BOTTLE (71610-999-70) | 120 capsule | 2026-04-14 | No | No | Historical |
| 71610-999-75 | 71610099975 | 150 CAPSULE in 1 BOTTLE (71610-999-75) | 150 capsule | 2026-04-21 | No | No | Historical |
| 71610-999-80 | 71610099980 | 180 CAPSULE in 1 BOTTLE (71610-999-80) | 180 capsule | 2026-05-04 | No | No | Historical |