PREGABALIN
- Product NDC
- 75834-303
- 11-digit product format
- 758340303
- Labeler code
- 75834
- Product ID
- 75834-303_3b93005b-dd76-4271-9b3c-f2f047285f13
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Nivagen Pharmaceuticals, Inc.
- Application
- ANDA212988
- Marketing category
- ANDA
- Marketing start
- 2022-07-14
- Marketing end
- 0000-00-00
- Substance
- PREGABALIN
- Active strength
- 300 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-303-05 | PREGABALIN | 500 in 1 BOTTLE | CAPSULE | 500 | | 1 |
| 75834-303-60 | PREGABALIN | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
| 75834-303-90 | 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 |
|---|
| 75834-303 | PREGABALIN CAPSULE [NIVAGEN PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 3 package rows | 20220728_388369d9-c76f-431f-89cc-20b39dd73bc3.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 |
|---|
| 75834-303-05 | 75834030305 | 500 CAPSULE in 1 BOTTLE (75834-303-05) | 500 capsule | 2022-07-14 | 0000-00-00 | No | No | Current |
| 75834-303-60 | 75834030360 | 60 CAPSULE in 1 BOTTLE (75834-303-60) | 60 capsule | 2022-07-14 | 0000-00-00 | No | No | Current |
| 75834-303-90 | 75834030390 | 90 CAPSULE in 1 BOTTLE (75834-303-90) | 90 capsule | 2022-07-14 | 0000-00-00 | No | No | Current |