Pregabalin
- Product NDC
- 69367-327
- 11-digit product format
- 693670327
- Labeler code
- 69367
- Product ID
- 69367-327_0efc2eea-ebae-47f9-a13a-f2df4331cf04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA208677
- Marketing category
- ANDA
- Marketing start
- 2021-08-24
- Substance
- PREGABALIN
- Active strength
- 100 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 | 100 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 |
|---|
| 69367-327-09 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-327 | PREGABALIN CAPSULE [WESTMINSTER PHARMACEUTICALS, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240405_781cb1ac-a0d2-4b47-b319-f0b90de86384.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 |
|---|
| 69367-327-09 | 69367032709 | 90 CAPSULE in 1 BOTTLE (69367-327-09) | 90 capsule | 2021-08-24 | 0000-00-00 | No | No | Current |