Prescription drug · NDA AUTHORIZED GENERIC
Aliskiren (aliskiren hemifumarate) NDC 66993-142
Aliskiren hemifumarate 300 mg/1 · Tablet, Film coated · Oral · Prasco Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66993-142-30 | 66993014230 | 30 TABLET, FILM COATED in 1 BOTTLE (66993-142-30)Marketed from Mar 4, 2019 |
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)
- Aliskiren
- Generic name (nonproprietary)
- aliskiren hemifumarate
- Active ingredients
- Aliskiren hemifumarate — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Prasco Laboratories
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021985
- Marketing start
- Listing expires
- Other FDA classes
- Renin Inhibitors (Mechanism)
- Identifiers
- Product ID 66993-142_9a21dde8-cd39-400b-933a-a74e907ffcbaSPL ID 9a21dde8-cd39-400b-933a-a74e907ffcbaSPL set ID 41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6dbRxCUI 1011736, 1011739UNII C8A0P8G029UPC 0366993142302, 0366993141305
- 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
N466993014230followed by a unit qualifier and the quantityPackage 66993-0142-30. 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)
Aliskiren 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 Aliskiren 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 …
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| Tekturnaaliskiren hemifumarate | Aliskiren hemifumarate 150 mg/1 | Tablet, Film coatedOral | LXO US Inc. | 70839-150 |
| Tekturnaaliskiren hemifumarate | Aliskiren hemifumarate 300 mg/1 | Tablet, Film coatedOral | LXO US Inc. | 70839-300 |
| Aliskirenaliskiren hemifumarate | Aliskiren hemifumarate 150 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-141 |