ALISKIREN
- Product NDC
- 49884-425
- 11-digit product format
- 498840425
- Labeler code
- 49884
- Product ID
- 49884-425_6c3a1f0c-dd67-4849-a8b5-a88f85ac5f43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ALISKIREN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- ANDA206665
- Marketing category
- ANDA
- Marketing start
- 2019-03-25
- Substance
- ALISKIREN HEMIFUMARATE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Renin Inhibitor [EPC], Renin Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ALISKIREN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALISKIREN HEMIFUMARATE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C8A0P8G029 |
| Rxcui | 1011736, 1011739 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49884-425-11 | ALISKIREN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 29 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-425 | ALISKIREN TABLET, FILM COATED [ENDO USA, INC.] | 29 | Current NDC, Legacy NDC, 1 package rows | 20240926_f3fd2503-25ef-4660-a29a-f62c491e28fb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49884-425-11 | 49884042511 | 30 TABLET, FILM COATED in 1 BOTTLE (49884-425-11) | 2019-03-25 | 0000-00-00 | No | No | Current |