candesartan cilexetil

Generic: candesartan cilexetil

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

Drug Facts

Product Profile

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

candesartan cilexetil 16 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-343
Product ID 46708-343_aaa63206-6c7d-4996-8991-91bfdb69b821
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210302
Listing Expiration 2026-12-31
Marketing Start 2018-12-05

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 46708343
Hyphenated Format 46708-343

Supplemental Identifiers

RxCUI
153822 153823 577776
UPC
0346708341305 0346708342302 0346708343309
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 ANDA210302 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 16 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (46708-343-30)
  • 90 TABLET in 1 BOTTLE (46708-343-90)
  • 1000 TABLET in 1 BOTTLE (46708-343-91)
source: ndc

Packages (3)

46708-343-30 30 TABLET in 1 BOTTLE (46708-343-30) 46708-343-90 90 TABLET in 1 BOTTLE (46708-343-90) 46708-343-91 1000 TABLET in 1 BOTTLE (46708-343-91)

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": "aaa63206-6c7d-4996-8991-91bfdb69b821", "openfda": {"upc": ["0346708341305", "0346708342302", "0346708343309"], "unii": ["R85M2X0D68"], "rxcui": ["153822", "153823", "577776"], "spl_set_id": ["d5b43fa0-6678-4219-99f1-10d273d49baf"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (46708-343-30)", "package_ndc": "46708-343-30", "marketing_start_date": "20181205"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (46708-343-90)", "package_ndc": "46708-343-90", "marketing_start_date": "20181205"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (46708-343-91)", "package_ndc": "46708-343-91", "marketing_start_date": "20181205"}], "brand_name": "CANDESARTAN CILEXETIL", "product_id": "46708-343_aaa63206-6c7d-4996-8991-91bfdb69b821", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "46708-343", "generic_name": "CANDESARTAN CILEXETIL", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CANDESARTAN CILEXETIL", "active_ingredients": [{"name": "CANDESARTAN CILEXETIL", "strength": "16 mg/1"}], "application_number": "ANDA210302", "marketing_category": "ANDA", "marketing_start_date": "20181205", "listing_expiration_date": "20261231"}