aliskiren

Generic: aliskiren

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aliskiren
Generic Name aliskiren
Labeler endo usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

aliskiren hemifumarate 300 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-425
Product ID 49884-425_6c3a1f0c-dd67-4849-a8b5-a88f85ac5f43
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206665
Listing Expiration 2026-12-31
Marketing Start 2019-03-25

Pharmacologic Class

Classes
renin inhibitor [epc] renin inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49884425
Hyphenated Format 49884-425

Supplemental Identifiers

RxCUI
1011736 1011739
UNII
C8A0P8G029

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name aliskiren (source: ndc)
Generic Name aliskiren (source: ndc)
Application Number ANDA206665 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (49884-425-11)
source: ndc

Packages (1)

49884-425-11 30 TABLET, FILM COATED in 1 BOTTLE (49884-425-11)

Ingredients (1)

aliskiren hemifumarate (300 mg/1)

Linked Drug Pages (1)

ALISKIREN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6c3a1f0c-dd67-4849-a8b5-a88f85ac5f43", "openfda": {"unii": ["C8A0P8G029"], "rxcui": ["1011736", "1011739"], "spl_set_id": ["f3fd2503-25ef-4660-a29a-f62c491e28fb"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (49884-425-11)", "package_ndc": "49884-425-11", "marketing_start_date": "20190325"}], "brand_name": "ALISKIREN", "product_id": "49884-425_6c3a1f0c-dd67-4849-a8b5-a88f85ac5f43", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Renin Inhibitor [EPC]", "Renin Inhibitors [MoA]"], "product_ndc": "49884-425", "generic_name": "ALISKIREN", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ALISKIREN", "active_ingredients": [{"name": "ALISKIREN HEMIFUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA206665", "marketing_category": "ANDA", "marketing_start_date": "20190325", "listing_expiration_date": "20261231"}