Tekturna
- Product NDC
- 70839-150
- 11-digit product format
- 708390150
- Labeler code
- 70839
- Product ID
- 70839-150_130d24ec-4b3b-0978-e063-6394a90af0c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- aliskiren hemifumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- LXO US Inc.
- Application
- NDA021985
- Marketing category
- NDA
- Marketing start
- 2007-03-05
- Substance
- ALISKIREN HEMIFUMARATE
- Active strength
- 150 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
- Tekturna
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALISKIREN HEMIFUMARATE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C8A0P8G029 |
| Rxcui | 1011736, 1011738, 1011739, 1011741 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70839-150-01 | Tekturna | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 16 |
| 70839-150-01 | Tekturna | 100 in 1 PACKAGE | TABLET, FILM COATED | 100 | | 16 |
| 70839-150-30 | Tekturna | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 16 |
| 70839-150-90 | Tekturna | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 16 |
| 70839-150-99 | Tekturna | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70839-150 | TEKTURNA (ALISKIREN HEMIFUMARATE) TABLET, FILM COATED [LXO US INC.] | 16 | Current NDC, Legacy NDC, 5 package rows | 20240312_3dd61fa5-1620-4ebf-bbdb-ede29b92fce2.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 |
|---|
| 70839-150-01 | 70839015001 | 1 in 1 BLISTER PACK | | | | | Historical |
| 70839-150-30 | 70839015030 | 30 TABLET, FILM COATED in 1 BOTTLE (70839-150-30) | 2017-01-01 | 0000-00-00 | No | No | Current |
| 70839-150-90 | 70839015090 | 90 in 1 BOTTLE | | | | | Historical |
| 70839-150-99 | 70839015099 | 7 in 1 BOTTLE | | | | | Historical |