Prescription drug · NDA
Tekturna (Aliskiren hemifumarate) NDC 70839-300
Aliskiren hemifumarate 300 mg/1 · Tablet, Film coated · Oral · LXO US Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70839-300-30 | 70839030030 | 30 TABLET, FILM COATED in 1 BOTTLE (70839-300-30)Marketed from Jan 1, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Tekturna
- Generic name (nonproprietary)
- aliskiren hemifumarate
- Active ingredients
- Aliskiren hemifumarate — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- LXO US Inc.NDC labeler code 70839
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021985
- Marketing start
- Listing expires
- Other FDA classes
- Renin Inhibitors (Mechanism)
- Identifiers
- Product ID 70839-300_130d24ec-4b3b-0978-e063-6394a90af0c8SPL ID 130d24ec-4b3b-0978-e063-6394a90af0c8SPL set ID 3dd61fa5-1620-4ebf-bbdb-ede29b92fce2RxCUI 1011736, 1011738, 1011739, 1011741UNII C8A0P8G029UPC 0370839300306
- Pharmacologic class
- Renin Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470839030030followed by a unit qualifier and the quantityPackage 70839-0300-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Tekturna is a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) 1.1 Hypertension Tekturna is indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age and older to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been se…
Excerpt only. Read the full label for complete information.
About NDC 70839-300
- What is NDC 70839-300?
- 70839-300 is the product NDC for Tekturna (aliskiren hemifumarate), Aliskiren hemifumarate 300 mg/1 tablet, film coated, listed with the FDA by LXO US Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tekturna (Aliskiren hemifumarate).
- What is the active ingredient?
- Aliskiren hemifumarate.
- Who is the labeler?
- LXO US Inc., NDC labeler code 70839. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tekturna?
- 1 other product NDC are listed under this name. See all Tekturna NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tekturna products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tekturnaaliskiren hemifumarate | Aliskiren hemifumarate 150 mg/1 | Tablet, Film coatedOral | LXO US Inc. | 70839-150 | 70839-0150-30 |
Other NDCs under NDA 021985
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Aliskirenaliskiren hemifumarate | Aliskiren hemifumarate 150 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-141 |
| Aliskirenaliskiren hemifumarate | Aliskiren hemifumarate 300 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-142 |
| Tekturnaaliskiren hemifumarate | Aliskiren hemifumarate 150 mg/1 | Tablet, Film coatedOral | LXO US Inc. | 70839-150 |