PREGABALIN
- Product NDC
- 72189-328
- 11-digit product format
- 721890328
- Labeler code
- 72189
- Product ID
- 72189-328_2c3d4146-03dd-30a9-e063-6294a90ad471
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Direct Rx
- Application
- ANDA208677
- Marketing category
- ANDA
- Marketing start
- 2022-02-21
- Substance
- PREGABALIN
- Active strength
- 225 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 | 225 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 577127 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-328-60 | PREGABALIN | 60 in 1 BOTTLE | CAPSULE | 60 | | 4 |
| 72189-328-90 | 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 |
|---|
| 72189-328 | PREGABALIN CAPSULE [DIRECT RX] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250122_d88925b8-9be6-d862-e053-2995a90a1612.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 |
|---|
| 72189-328-60 | 72189032860 | 60 CAPSULE in 1 BOTTLE (72189-328-60) | 60 capsule | 2022-02-21 | 0000-00-00 | No | No | Current |
| 72189-328-90 | 72189032890 | 90 CAPSULE in 1 BOTTLE (72189-328-90) | 90 capsule | 2022-02-21 | 0000-00-00 | No | No | Current |