Pregabalin
- Product NDC
- 69238-1312
- 11-digit product format
- 692381312
- Labeler code
- 69238
- Product ID
- 69238-1312_670cafeb-c249-4782-838c-9537d3ede28b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA209743
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Substance
- PREGABALIN
- Active strength
- 75 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 | 75 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 |
|---|
| 69238-1312-5 | Pregabalin | 500 in 1 BOTTLE | CAPSULE | 500 | | 8 |
| 69238-1312-9 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1312 | PREGABALIN CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240807_3d9d7123-5886-4b61-a7ea-471b213e77d9.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 |
|---|
| 69238-1312-5 | 69238131205 | 500 CAPSULE in 1 BOTTLE (69238-1312-5) | 500 capsule | 2019-07-19 | | No | No | Current |
| 69238-1312-9 | 69238131209 | 90 CAPSULE in 1 BOTTLE (69238-1312-9) | 90 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |