candesartan

Generic: candesartan

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name candesartan
Generic Name candesartan
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

candesartan cilexetil 16 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-116
Product ID 33342-116_4079c843-42ee-4f7a-a4a0-9498ba6cf12d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203813
Listing Expiration 2026-12-31
Marketing Start 2016-12-06

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 33342116
Hyphenated Format 33342-116

Supplemental Identifiers

RxCUI
153822 153823 577776 639537
UPC
0333342117106 0333342116109 0333342114105 0333342114075 0333342116079 0333342117076 0333342115072 0333342114129 0333342115102 0333342117120 0333342115126 0333342116123
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 (source: ndc)
Generic Name candesartan (source: ndc)
Application Number ANDA203813 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 16 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 CONTAINER (33342-116-07)
  • 90 TABLET in 1 CONTAINER (33342-116-10)
  • 10 BLISTER PACK in 1 CARTON (33342-116-12) / 10 TABLET in 1 BLISTER PACK
  • 300 TABLET in 1 CONTAINER (33342-116-51)
source: ndc

Packages (4)

33342-116-07 30 TABLET in 1 CONTAINER (33342-116-07) 33342-116-10 90 TABLET in 1 CONTAINER (33342-116-10) 33342-116-12 10 BLISTER PACK in 1 CARTON (33342-116-12) / 10 TABLET in 1 BLISTER PACK 33342-116-51 300 TABLET in 1 CONTAINER (33342-116-51)

Ingredients (1)

candesartan cilexetil (16 mg/1)

Linked Drug Pages (1)

Candesartan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4079c843-42ee-4f7a-a4a0-9498ba6cf12d", "openfda": {"upc": ["0333342117106", "0333342116109", "0333342114105", "0333342114075", "0333342116079", "0333342117076", "0333342115072", "0333342114129", "0333342115102", "0333342117120", "0333342115126", "0333342116123"], "unii": ["R85M2X0D68"], "rxcui": ["153822", "153823", "577776", "639537"], "spl_set_id": ["8ceb5658-b03c-475d-9ef0-2cd0645191d3"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 CONTAINER (33342-116-07)", "package_ndc": "33342-116-07", "marketing_start_date": "20161206"}, {"sample": false, "description": "90 TABLET in 1 CONTAINER (33342-116-10)", "package_ndc": "33342-116-10", "marketing_start_date": "20161206"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-116-12)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "33342-116-12", "marketing_start_date": "20161206"}, {"sample": false, "description": "300 TABLET in 1 CONTAINER (33342-116-51)", "package_ndc": "33342-116-51", "marketing_start_date": "20161206"}], "brand_name": "Candesartan", "product_id": "33342-116_4079c843-42ee-4f7a-a4a0-9498ba6cf12d", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "33342-116", "generic_name": "Candesartan", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Candesartan", "active_ingredients": [{"name": "CANDESARTAN CILEXETIL", "strength": "16 mg/1"}], "application_number": "ANDA203813", "marketing_category": "ANDA", "marketing_start_date": "20161206", "listing_expiration_date": "20261231"}