Pregabalin
- Product NDC
- 55700-827
- 11-digit product format
- 557000827
- Labeler code
- 55700
- Product ID
- 55700-827_33639a82-c751-4371-a085-68e9e0329447
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA208677
- Marketing category
- ANDA
- Marketing start
- 2019-12-03
- Marketing end
- 2027-06-30
- Substance
- PREGABALIN
- Active strength
- 25 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pregabalin
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREGABALIN | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483442 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55700-827-90 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55700-827 | PREGABALIN CAPSULE [QUALITY CARE PRODUCTS, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241220_1e087436-0534-4de2-b310-a5cc0e46adbd.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 |
|---|
| 55700-827-90 | 55700082790 | 90 CAPSULE in 1 BOTTLE (55700-827-90) | 90 capsule | 2019-12-03 | 2027-06-30 | No | No | Current |