ambrisentan

Generic: ambrisentan

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

Drug Facts

Product Profile

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

ambrisentan 10 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-387
Product ID 69097-387_7921a3aa-6e99-4f28-a5d3-a3047b1ec3cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210715
Listing Expiration 2026-12-31
Marketing Start 2019-04-26

Pharmacologic Class

Established (EPC)
endothelin receptor antagonist [epc]
Mechanism of Action
endothelin receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097387
Hyphenated Format 69097-387

Supplemental Identifiers

RxCUI
722116 722122
UPC
0369097387020 0369097386023
UNII
HW6NV07QEC
NUI
N0000175581 N0000175364

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 ambrisentan (source: ndc)
Generic Name ambrisentan (source: ndc)
Application Number ANDA210715 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-387-02)
  • 1 BLISTER PACK in 1 CARTON (69097-387-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

69097-387-02 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-387-02) 69097-387-19 1 BLISTER PACK in 1 CARTON (69097-387-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

ambrisentan (10 mg/1)

Linked Drug Pages (1)

Ambrisentan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7921a3aa-6e99-4f28-a5d3-a3047b1ec3cc", "openfda": {"nui": ["N0000175581", "N0000175364"], "upc": ["0369097387020", "0369097386023"], "unii": ["HW6NV07QEC"], "rxcui": ["722116", "722122"], "spl_set_id": ["0e418384-cae1-47ae-ac5e-afc845d694f6"], "pharm_class_epc": ["Endothelin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Endothelin Receptor Antagonists [MoA]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-387-02)", "package_ndc": "69097-387-02", "marketing_start_date": "20190426"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69097-387-19)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "69097-387-19", "marketing_start_date": "20190426"}], "brand_name": "Ambrisentan", "product_id": "69097-387_7921a3aa-6e99-4f28-a5d3-a3047b1ec3cc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]"], "product_ndc": "69097-387", "generic_name": "Ambrisentan", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ambrisentan", "active_ingredients": [{"name": "AMBRISENTAN", "strength": "10 mg/1"}], "application_number": "ANDA210715", "marketing_category": "ANDA", "marketing_start_date": "20190426", "listing_expiration_date": "20261231"}