pregabalin
- Product NDC
- 14445-126
- 11-digit product format
- 144450126
- Labeler code
- 14445
- Product ID
- 14445-126_522b3d6c-10fb-4581-afb7-2e48150b6048
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Indoco Remedies Limited
- Application
- ANDA208113
- Marketing category
- ANDA
- Marketing start
- 2024-05-17
- Substance
- PREGABALIN
- Active strength
- 200 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 | 200 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 |
|---|
| 14445-126-90 | pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 14445-126 | PREGABALIN CAPSULE [INDOCO REMEDIES LIMITED ] | 1 | Current NDC, 1 package rows | 20240601_0a8d9e35-46fd-4c70-bb7f-4e8b754f2794.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 |
|---|
| 14445-126-90 | 14445012690 | 90 CAPSULE in 1 BOTTLE (14445-126-90) | 90 capsule | 2024-05-17 | No | No | Historical |