PREGABALIN
- Product NDC
- 72658-0808
- 11-digit product format
- 726580808
- Labeler code
- 72658
- Product ID
- 72658-0808_4739c18b-9a48-41df-e063-6394a90a3589
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Eskayef Pharmaceuticals Limited
- Application
- ANDA212988
- Marketing category
- ANDA
- Marketing start
- 2022-04-04
- Substance
- PREGABALIN
- Active strength
- 25 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 | 25 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 |
|---|
| 72658-0808-1 | PREGABALIN | 60 in 1 BOTTLE | CAPSULE | 60 | | 9 |
| 72658-0808-2 | PREGABALIN | 90 in 1 BOTTLE | CAPSULE | 90 | | 9 |
| 72658-0808-6 | PREGABALIN | 500 in 1 BOTTLE | CAPSULE | 500 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72658-0808 | PREGABALIN CAPSULE [ESKAYEF PHARMACEUTICALS LIMITED] | 8 | Current NDC, Legacy NDC, 3 package rows | 20230809_65d9e751-61c2-4741-85c0-2526cfdc765c.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 |
|---|
| 72658-0808-1 | 72658080801 | 60 CAPSULE in 1 BOTTLE (72658-0808-1) | 60 capsule | 2022-04-04 | 0000-00-00 | No | No | Current |
| 72658-0808-2 | 72658080802 | 90 CAPSULE in 1 BOTTLE (72658-0808-2) | 90 capsule | 2022-04-04 | 0000-00-00 | No | No | Current |
| 72658-0808-6 | 72658080806 | 500 CAPSULE in 1 BOTTLE (72658-0808-6) | 500 capsule | 2022-04-04 | 0000-00-00 | No | No | Current |