Pregabalin
- Product NDC
- 62135-446
- 11-digit product format
- 621350446
- Labeler code
- 62135
- Product ID
- 62135-446_4361bef4-846b-7589-e063-6294a90a9292
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA212865
- Marketing category
- ANDA
- Marketing start
- 2020-03-31
- Substance
- PREGABALIN
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483438, 483440, 483448, 483450 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-446-90 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-446 | PREGABALIN CAPSULE [CHARTWELL RX, LLC] | 2 | Current NDC, 1 package rows | 20241031_13d03119-e49b-482e-b5f9-d40dc3f4862e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-446-90 | 62135044690 | 90 CAPSULE in 1 BOTTLE (62135-446-90) | 90 capsule | 2025-07-25 | No | No | Current |