Pregabalin
- Product NDC
- 71205-396
- 11-digit product format
- 712050396
- Labeler code
- 71205
- Product ID
- 71205-396_9619e38d-3a8c-49ce-a54d-a633f571d25c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA208677
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Substance
- PREGABALIN
- Active strength
- 150 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483440 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-396-30 | Pregabalin | 30 in 1 BOTTLE | CAPSULE | 30 | | 2 |
| 71205-396-60 | Pregabalin | 60 in 1 BOTTLE | CAPSULE | 60 | | 2 |
| 71205-396-90 | 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 |
|---|
| 71205-396 | PREGABALIN CAPSULE [PROFICIENT RX LP] | 2 | Current NDC, Legacy NDC, 3 package rows | 20220421_a0f2b8af-0a04-4db0-adb3-d9d9369223d9.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 |
|---|
| 71205-396-30 | 71205039630 | 30 CAPSULE in 1 BOTTLE (71205-396-30) | 30 capsule | 2020-02-05 | 0000-00-00 | No | No | Current |
| 71205-396-60 | 71205039660 | 60 CAPSULE in 1 BOTTLE (71205-396-60) | 60 capsule | 2020-02-05 | 0000-00-00 | No | No | Current |
| 71205-396-90 | 71205039690 | 90 CAPSULE in 1 BOTTLE (71205-396-90) | 90 capsule | 2020-02-05 | 0000-00-00 | No | No | Current |