candesartan cilexetil

Generic: candesartan cilexetil

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name candesartan cilexetil
Generic Name candesartan cilexetil
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

candesartan cilexetil 16 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-3231
Product ID 0378-3231_62815e9d-598e-4b5f-b33b-3a9659eec024
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078702
Listing Expiration 2026-12-31
Marketing Start 2020-01-06

Pharmacologic Class

Classes
angiotensin 2 receptor antagonists [moa] angiotensin 2 receptor blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03783231
Hyphenated Format 0378-3231

Supplemental Identifiers

RxCUI
153822 153823 577776 639537
UPC
0303783232935 0303783225937 0303783224930
UNII
R85M2X0D68

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 candesartan cilexetil (source: ndc)
Generic Name candesartan cilexetil (source: ndc)
Application Number ANDA078702 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 16 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (0378-3231-77)
  • 30 TABLET in 1 BOTTLE, PLASTIC (0378-3231-93)
source: ndc

Packages (2)

0378-3231-77 90 TABLET in 1 BOTTLE, PLASTIC (0378-3231-77) 0378-3231-93 30 TABLET in 1 BOTTLE, PLASTIC (0378-3231-93)

Ingredients (1)

candesartan cilexetil (16 mg/1)

Linked Drug Pages (1)

candesartan cilexetil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "62815e9d-598e-4b5f-b33b-3a9659eec024", "openfda": {"upc": ["0303783232935", "0303783225937", "0303783224930"], "unii": ["R85M2X0D68"], "rxcui": ["153822", "153823", "577776", "639537"], "spl_set_id": ["904b357e-97bf-475e-90a5-f0449f2a428e"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (0378-3231-77)", "package_ndc": "0378-3231-77", "marketing_start_date": "20200106"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (0378-3231-93)", "package_ndc": "0378-3231-93", "marketing_start_date": "20200106"}], "brand_name": "candesartan cilexetil", "product_id": "0378-3231_62815e9d-598e-4b5f-b33b-3a9659eec024", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "0378-3231", "generic_name": "candesartan cilexetil", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "candesartan cilexetil", "active_ingredients": [{"name": "CANDESARTAN CILEXETIL", "strength": "16 mg/1"}], "application_number": "ANDA078702", "marketing_category": "ANDA", "marketing_start_date": "20200106", "listing_expiration_date": "20261231"}