Pregabalin
- Product NDC
- 67877-462
- 11-digit product format
- 678770462
- Labeler code
- 67877
- Product ID
- 67877-462_bf3e2485-edec-4163-b3ff-0e671f12df15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA207799
- Marketing category
- ANDA
- Marketing start
- 2019-10-02
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-462 | PREGABALIN CAPSULE [ASCEND LABORATORIES, LLC] | 16 | Current NDC, Legacy NDC, 7 package rows | 20240830_e48db3c2-7351-41f2-a451-5a8341c4125c.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 |
|---|
| 67877-462-05 | 67877046205 | 500 CAPSULE in 1 BOTTLE (67877-462-05) | 500 capsule | 2019-10-02 | 0000-00-00 | No | No | Current |
| 67877-462-30 | 67877046230 | 30 CAPSULE in 1 BOTTLE (67877-462-30) | 30 capsule | 2019-10-02 | 0000-00-00 | No | No | Current |
| 67877-462-33 | 67877046233 | 1 BLISTER PACK in 1 CARTON (67877-462-33) / 10 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2019-10-02 | 0000-00-00 | No | No | Current |
| 67877-462-38 | 67877046238 | 10 BLISTER PACK in 1 CARTON (67877-462-38) / 10 CAPSULE in 1 BLISTER PACK | 10 blister pack | 2019-10-02 | 0000-00-00 | No | No | Current |
| 67877-462-90 | 67877046290 | 90 CAPSULE in 1 BOTTLE (67877-462-90) | 90 capsule | 2019-10-02 | 0000-00-00 | No | No | Current |