Aliskiren NDC 49884-425

NDC codes

FDA NDC Directory

Product NDC (as listed)49884-425Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49884-0425Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
49884-425-11	49884042511	30 TABLET, FILM COATED in 1 BOTTLE (49884-425-11)Marketed from Mar 25, 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
Active ingredients: Aliskiren hemifumarate — 300 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Par Health USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206665
Marketing start: Mar 25, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Renin Inhibitors (Mechanism)
Identifiers: Product ID 49884-425_640e0067-1ca8-4509-9b69-0f525caca6deSPL ID 640e0067-1ca8-4509-9b69-0f525caca6deSPL set ID f3fd2503-25ef-4660-a29a-f62c491e28fbRxCUI 1011736, 1011739UNII C8A0P8G029UPC 0349884424114
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

N449884042511 followed by a unit qualifier and the quantity

Package 49884-0425-11. 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 Dec 30, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Aliskiren tablets are 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 Hypertension Aliskiren tablets are 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206665

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 206665
Product	Strength	Form · route	Labeler	Product NDC
Aliskiren	Aliskiren hemifumarate 150 mg/1	Tablet, Film coatedOral	Par Health USA, LLC	49884-424