Pregabalin
- Product NDC
- 72205-012
- 11-digit product format
- 722050012
- Labeler code
- 72205
- Product ID
- 72205-012_d1428cf2-1243-43cb-8b54-f46024dbca29
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA209357
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Substance
- PREGABALIN
- Active strength
- 50 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 | 50 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 |
|---|
| 72205-012-06 | Pregabalin | 100 in 1 CARTON | CAPSULE | 100 | | 6 |
| 72205-012-11 | Pregabalin | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 6 |
| 72205-012-90 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | | 6 |
| 72205-012-99 | Pregabalin | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72205-012 | PREGABALIN CAPSULE [NOVADOZ PHARMACEUTICALS LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20230308_193666f7-3c55-43b1-947a-2ffec40c687f.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 |
|---|
| 72205-012-06 | 72205001206 | 100 BLISTER PACK in 1 CARTON (72205-012-06) / 10 CAPSULE in 1 BLISTER PACK (72205-012-11) | 100 blister pack | 2019-07-19 | 0000-00-00 | No | No | Current |
| 72205-012-11 | 72205001211 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 72205-012-90 | 72205001290 | 90 CAPSULE in 1 BOTTLE (72205-012-90) | 90 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |
| 72205-012-99 | 72205001299 | 1000 CAPSULE in 1 BOTTLE (72205-012-99) | 1000 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |