PREGABALIN
- Product NDC
- 43547-513
- 11-digit product format
- 435470513
- Labeler code
- 43547
- Product ID
- 43547-513_e7ff85eb-a068-40a7-88f0-4fa6abf6375e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA207883
- Marketing category
- ANDA
- Marketing start
- 2020-06-15
- Substance
- PREGABALIN
- Active strength
- 300 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 | 300 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 |
|---|
| 43547-513-09 | PREGABALIN | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
| 43547-513-50 | PREGABALIN | 500 in 1 BOTTLE | CAPSULE | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-513 | PREGABALIN CAPSULE [SOLCO HEALTHCARE US, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240706_085db834-3735-40d9-ac67-f9dbb82390c5.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 |
|---|
| 43547-513-09 | 43547051309 | 90 CAPSULE in 1 BOTTLE (43547-513-09) | 90 capsule | 2020-06-15 | 0000-00-00 | No | No | Current |
| 43547-513-50 | 43547051350 | 500 CAPSULE in 1 BOTTLE (43547-513-50) | 500 capsule | 2020-06-15 | 0000-00-00 | No | No | Current |