telmisartan

Generic: telmisartan

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

Drug Facts

Product Profile

Brand Name telmisartan
Generic Name telmisartan
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telmisartan 80 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-473
Product ID 68382-473_99f660d2-4407-490e-a79f-6523bece714d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203325
Listing Expiration 2026-12-31
Marketing Start 2014-08-27

Pharmacologic Class

Established (EPC)
angiotensin 2 receptor blocker [epc]
Mechanism of Action
angiotensin 2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382473
Hyphenated Format 68382-473

Supplemental Identifiers

RxCUI
205304 205305 282755
UNII
U5SYW473RQ
NUI
N0000000070 N0000175561

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 telmisartan (source: ndc)
Generic Name telmisartan (source: ndc)
Application Number ANDA203325 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-473-01)
  • 500 TABLET in 1 BOTTLE (68382-473-05)
  • 30 TABLET in 1 BOTTLE (68382-473-06)
  • 1000 TABLET in 1 BOTTLE (68382-473-10)
  • 90 TABLET in 1 BOTTLE (68382-473-16)
  • 30 BLISTER PACK in 1 CARTON (68382-473-78) / 1 TABLET in 1 BLISTER PACK (68382-473-30)
source: ndc

Packages (6)

68382-473-01 100 TABLET in 1 BOTTLE (68382-473-01) 68382-473-05 500 TABLET in 1 BOTTLE (68382-473-05) 68382-473-06 30 TABLET in 1 BOTTLE (68382-473-06) 68382-473-10 1000 TABLET in 1 BOTTLE (68382-473-10) 68382-473-16 90 TABLET in 1 BOTTLE (68382-473-16) 68382-473-78 30 BLISTER PACK in 1 CARTON (68382-473-78) / 1 TABLET in 1 BLISTER PACK (68382-473-30)

Ingredients (1)

telmisartan (80 mg/1)

Linked Drug Pages (1)

telmisartan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "99f660d2-4407-490e-a79f-6523bece714d", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["U5SYW473RQ"], "rxcui": ["205304", "205305", "282755"], "spl_set_id": ["e61c209a-4fc3-4f5c-b526-6412f0b8897c"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-473-01)", "package_ndc": "68382-473-01", "marketing_start_date": "20140827"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-473-05)", "package_ndc": "68382-473-05", "marketing_start_date": "20140827"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68382-473-06)", "package_ndc": "68382-473-06", "marketing_start_date": "20140827"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68382-473-10)", "package_ndc": "68382-473-10", "marketing_start_date": "20140827"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-473-16)", "package_ndc": "68382-473-16", "marketing_start_date": "20140827"}, {"sample": false, "description": "30 BLISTER PACK in 1 CARTON (68382-473-78)  / 1 TABLET in 1 BLISTER PACK (68382-473-30)", "package_ndc": "68382-473-78", "marketing_start_date": "20140827"}], "brand_name": "telmisartan", "product_id": "68382-473_99f660d2-4407-490e-a79f-6523bece714d", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "68382-473", "generic_name": "telmisartan", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "telmisartan", "active_ingredients": [{"name": "TELMISARTAN", "strength": "80 mg/1"}], "application_number": "ANDA203325", "marketing_category": "ANDA", "marketing_start_date": "20140827", "listing_expiration_date": "20261231"}