Pregabalin
- Product NDC
- 71610-318
- 11-digit product format
- 716100318
- Labeler code
- 71610
- Product ID
- 71610-318_9d6ac8b5-77e4-4c4f-9c24-8d3043149146
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA211384
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Substance
- PREGABALIN
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-318-30 | Pregabalin | 30 in 1 BOTTLE | CAPSULE | 30 | | 11 |
| 71610-318-46 | Pregabalin | 56 in 1 BOTTLE | CAPSULE | 56 | | 11 |
| 71610-318-53 | Pregabalin | 60 in 1 BOTTLE | CAPSULE | 60 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-318 | PREGABALIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 8 | Current NDC, Legacy NDC, 3 package rows | 20240305_bf710bcf-75ed-4184-b9c3-81cd05a780a4.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 |
|---|
| 71610-318-30 | 71610031830 | 30 CAPSULE in 1 BOTTLE (71610-318-30) | 30 capsule | 2023-12-21 | | No | No | Current |
| 71610-318-46 | 71610031846 | 56 CAPSULE in 1 BOTTLE (71610-318-46) | 56 capsule | 2023-12-21 | | No | No | Current |
| 71610-318-53 | 71610031853 | 60 CAPSULE in 1 BOTTLE (71610-318-53) | 60 capsule | 2019-08-12 | 0000-00-00 | No | No | Current |