Pregabalin
- Product NDC
- 31722-612
- 11-digit product format
- 317220612
- Labeler code
- 31722
- Product ID
- 31722-612_3ff00691-3fde-ae93-e063-6294a90adcc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA206912
- Marketing category
- ANDA
- Marketing start
- 2019-10-08
- 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 |
|---|
| 31722-612-05 | Pregabalin | 500 in 1 BOTTLE | CAPSULE | 500 | | 3 |
| 31722-612-31 | Pregabalin | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 3 |
| 31722-612-31 | Pregabalin | 10 in 1 CARTON | CAPSULE | 10 | | 3 |
| 31722-612-60 | Pregabalin | 60 in 1 BOTTLE | CAPSULE | 60 | | 3 |
| 31722-612-90 | 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 |
|---|
| 31722-612 | PREGABALIN (PREGABALIN) CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 5 package rows | 20240713_241c4b7e-f719-4828-8639-ea613b8a6583.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 |
|---|
| 31722-612-05 | 31722061205 | 500 CAPSULE in 1 BOTTLE (31722-612-05) | 500 capsule | 2019-10-08 | 0000-00-00 | No | No | Current |
| 31722-612-31 | 31722061231 | 10 BLISTER PACK in 1 CARTON (31722-612-31) / 10 CAPSULE in 1 BLISTER PACK | 10 blister pack | 2019-10-08 | 0000-00-00 | No | No | Current |
| 31722-612-60 | 31722061260 | 60 CAPSULE in 1 BOTTLE (31722-612-60) | 60 capsule | 2019-10-08 | 0000-00-00 | No | No | Current |
| 31722-612-90 | 31722061290 | 90 CAPSULE in 1 BOTTLE (31722-612-90) | 90 capsule | 2019-10-08 | 0000-00-00 | No | No | Current |