Pregabalin
- Product NDC
- 13668-359
- 11-digit product format
- 136680359
- Labeler code
- 13668
- Product ID
- 13668-359_f28a120a-aea5-45b9-84f7-06f48f41bc03
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA206942
- Marketing category
- ANDA
- Marketing start
- 2025-05-19
- Substance
- PREGABALIN
- Active strength
- 50 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 | 50 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 |
|---|
| 13668-359-01 | Pregabalin | 100 in 1 BOTTLE | CAPSULE | 100 | | 12 |
| 13668-359-05 | Pregabalin | 500 in 1 BOTTLE | CAPSULE | 500 | | 12 |
| 13668-359-30 | Pregabalin | 30 in 1 BOTTLE | CAPSULE | 30 | | 12 |
| 13668-359-60 | Pregabalin | 60 in 1 BOTTLE | CAPSULE | 60 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-359 | PREGABALIN CAPSULE [TORRENT PHARMACEUTICALS LIMITED] | 10 | Current NDC, 4 package rows | 20250520_a062e78a-16ff-4d83-b700-0badb7d812d5.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 |
|---|
| 13668-359-01 | 13668035901 | 100 CAPSULE in 1 BOTTLE (13668-359-01) | 100 capsule | 2025-05-19 | No | No | Current |
| 13668-359-05 | 13668035905 | 500 CAPSULE in 1 BOTTLE (13668-359-05) | 500 capsule | 2025-05-19 | No | No | Current |
| 13668-359-30 | 13668035930 | 30 CAPSULE in 1 BOTTLE (13668-359-30) | 30 capsule | 2025-05-19 | No | No | Current |
| 13668-359-60 | 13668035960 | 60 CAPSULE in 1 BOTTLE (13668-359-60) | 60 capsule | 2025-05-19 | No | No | Current |