PREGABALIN
- Product NDC
- 76420-117
- 11-digit product format
- 764200117
- Labeler code
- 76420
- Product ID
- 76420-117_a8e4e23f-490f-7ebc-e053-2a95a90af171
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA210432
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Substance
- PREGABALIN
- Active strength
- 25 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 | 25 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 |
|---|
| 76420-117-30 | PREGABALIN | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 76420-117-60 | PREGABALIN | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
| 76420-117-90 | PREGABALIN | 90 in 1 BOTTLE | CAPSULE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-117 | PREGABALIN CAPSULE [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC, 3 package rows | 20200626_69b8a843-a3a8-4d76-8418-f48288625030.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 |
|---|
| 76420-117-30 | 76420011730 | 30 CAPSULE in 1 BOTTLE (76420-117-30) | 30 capsule | 2020-06-25 | 0000-00-00 | No | No | Current |
| 76420-117-60 | 76420011760 | 60 CAPSULE in 1 BOTTLE (76420-117-60) | 60 capsule | 2020-06-25 | 0000-00-00 | No | No | Current |
| 76420-117-90 | 76420011790 | 90 CAPSULE in 1 BOTTLE (76420-117-90) | 90 capsule | 2020-06-25 | 0000-00-00 | No | No | Current |