PREGABALIN
- Product NDC
- 82968-009
- 11-digit product format
- 829680009
- Labeler code
- 82968
- Product ID
- 82968-009_4c41b54b-827a-1d04-e063-6394a90a55ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED
- Application
- ANDA218529
- Marketing category
- ANDA
- Marketing start
- 2026-02-24
- Substance
- PREGABALIN
- Active strength
- 100 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PREGABALIN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREGABALIN | 100 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 |
|---|
| 82968-009-02 | PREGABALIN | 90 in 1 BOTTLE | CAPSULE | 90 | | 1 |
| 82968-009-04 | PREGABALIN | 100 in 1 CARTON | CAPSULE | 100 | | 1 |
| 82968-009-04 | PREGABALIN | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82968-009-02 | 82968000902 | 90 CAPSULE in 1 BOTTLE (82968-009-02) | 90 capsule | 2026-02-24 | No | No | Current |
| 82968-009-04 | 82968000904 | 100 BLISTER PACK in 1 CARTON (82968-009-04) / 1 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2026-02-24 | No | No | Current |