PREGABALIN
- Product NDC
- 82619-123
- 11-digit product format
- 826190123
- Labeler code
- 82619
- Product ID
- 82619-123_40b92ce3-6161-36b7-e063-6394a90af51e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Creekwood Pharmaceuticals LLC
- Application
- ANDA213423
- Marketing category
- ANDA
- Marketing start
- 2024-09-20
- Substance
- PREGABALIN
- Active strength
- 50 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 | 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 |
|---|
| 82619-123-01 | PREGABALIN | 90 in 1 BOTTLE | CAPSULE | 90 | | 5 |
| 82619-123-02 | PREGABALIN | 500 in 1 BOTTLE | CAPSULE | 500 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82619-123 | PREGABALIN CAPSULE [CREEKWOOD PHARMACEUTICALS LLC] | 1 | Current NDC, 2 package rows | 20240920_bfe4108e-b2d2-4059-be16-21d3276c3ae4.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 |
|---|
| 82619-123-01 | 82619012301 | 90 CAPSULE in 1 BOTTLE (82619-123-01) | 90 capsule | 2024-09-20 | No | No | Historical |
| 82619-123-02 | 82619012302 | 500 CAPSULE in 1 BOTTLE (82619-123-02) | 500 capsule | 2024-09-20 | No | No | Historical |