aliskiren

Generic: aliskiren hemifumarate

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name aliskiren
Generic Name aliskiren hemifumarate
Labeler prasco laboratories
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

aliskiren hemifumarate 150 mg/1

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-141
Product ID 66993-141_9a21dde8-cd39-400b-933a-a74e907ffcba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021985
Listing Expiration 2026-12-31
Marketing Start 2019-03-04

Pharmacologic Class

Classes
renin inhibitor [epc] renin inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66993141
Hyphenated Format 66993-141

Supplemental Identifiers

RxCUI
1011736 1011739
UPC
0366993142302 0366993141305
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 hemifumarate (source: ndc)
Application Number NDA021985 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (66993-141-30)
source: ndc

Packages (1)

66993-141-30 30 TABLET, FILM COATED in 1 BOTTLE (66993-141-30)

Ingredients (1)

aliskiren hemifumarate (150 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": "9a21dde8-cd39-400b-933a-a74e907ffcba", "openfda": {"upc": ["0366993142302", "0366993141305"], "unii": ["C8A0P8G029"], "rxcui": ["1011736", "1011739"], "spl_set_id": ["41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6db"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (66993-141-30)", "package_ndc": "66993-141-30", "marketing_start_date": "20190304"}], "brand_name": "Aliskiren", "product_id": "66993-141_9a21dde8-cd39-400b-933a-a74e907ffcba", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Renin Inhibitor [EPC]", "Renin Inhibitors [MoA]"], "product_ndc": "66993-141", "generic_name": "aliskiren hemifumarate", "labeler_name": "Prasco Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aliskiren", "active_ingredients": [{"name": "ALISKIREN HEMIFUMARATE", "strength": "150 mg/1"}], "application_number": "NDA021985", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190304", "listing_expiration_date": "20261231"}