PREGABALIN
- Product NDC
- 55700-774
- 11-digit product format
- 557000774
- Labeler code
- 55700
- Product ID
- 55700-774_80e9650e-0f5b-4ab3-8758-d2f9b19d67e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA210432
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Marketing end
- 2026-12-31
- Substance
- PREGABALIN
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483438, 483440, 483448, 483450 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55700-774-30 | PREGABALIN | 30 in 1 BOTTLE | CAPSULE | 30 | | 11 |
| 55700-774-60 | PREGABALIN | 60 in 1 BOTTLE | CAPSULE | 60 | | 11 |
| 55700-774-90 | PREGABALIN | 90 in 1 BOTTLE | CAPSULE | 90 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55700-774 | PREGABALIN CAPSULE [QUALITY CARE PRODUCTS, LLC] | 11 | Current NDC, Legacy NDC, 3 package rows | 20241220_ff386af0-17d3-4f95-803b-b51cb79e5295.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 |
|---|
| 55700-774-30 | 55700077430 | 30 CAPSULE in 1 BOTTLE (55700-774-30) | 30 capsule | 2019-07-19 | 2026-12-31 | No | No | Current |
| 55700-774-60 | 55700077460 | 60 CAPSULE in 1 BOTTLE (55700-774-60) | 60 capsule | 2019-07-19 | 2026-12-31 | No | No | Current |
| 55700-774-90 | 55700077490 | 90 CAPSULE in 1 BOTTLE (55700-774-90) | 90 capsule | 2019-07-19 | 2026-12-31 | No | No | Current |