Pregabalin
- Product NDC
- 71610-619
- 11-digit product format
- 716100619
- Labeler code
- 71610
- Product ID
- 71610-619_d2de5bd4-13ac-4b83-8fa2-a75513e408fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA208677
- 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 | 483440, 483448 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-619-53 | Pregabalin | 60 in 1 BOTTLE | CAPSULE | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-619 | PREGABALIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240730_aa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec.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 |
|---|
| 71610-619-53 | 71610061953 | 60 CAPSULE in 1 BOTTLE (71610-619-53) | 60 capsule | 2021-12-02 | 0000-00-00 | No | No | Current |