telmisartan

Generic: telmisartan

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan
Generic Name telmisartan
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telmisartan 20 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-291
Product ID 65162-291_1a0e1325-40d8-4dde-8655-54f6bd962a4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204415
Listing Expiration 2026-12-31
Marketing Start 2013-05-31

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 65162291
Hyphenated Format 65162-291

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 ANDA204415 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (65162-291-03)
  • 90 TABLET in 1 BOTTLE (65162-291-09)
  • 500 TABLET in 1 BOTTLE (65162-291-50)
  • 3 BLISTER PACK in 1 CARTON (65162-291-63) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (4)

65162-291-03 30 TABLET in 1 BOTTLE (65162-291-03) 65162-291-09 90 TABLET in 1 BOTTLE (65162-291-09) 65162-291-50 500 TABLET in 1 BOTTLE (65162-291-50) 65162-291-63 3 BLISTER PACK in 1 CARTON (65162-291-63) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

telmisartan (20 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": "1a0e1325-40d8-4dde-8655-54f6bd962a4f", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["U5SYW473RQ"], "rxcui": ["205304", "205305", "282755"], "spl_set_id": ["20a60231-64f0-4751-aa81-6c0e64334179"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-291-03)", "package_ndc": "65162-291-03", "marketing_start_date": "20130531"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65162-291-09)", "package_ndc": "65162-291-09", "marketing_start_date": "20130531"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65162-291-50)", "package_ndc": "65162-291-50", "marketing_start_date": "20130531"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65162-291-63)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "65162-291-63", "marketing_start_date": "20130531"}], "brand_name": "Telmisartan", "product_id": "65162-291_1a0e1325-40d8-4dde-8655-54f6bd962a4f", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "65162-291", "generic_name": "Telmisartan", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Telmisartan", "active_ingredients": [{"name": "TELMISARTAN", "strength": "20 mg/1"}], "application_number": "ANDA204415", "marketing_category": "ANDA", "marketing_start_date": "20130531", "listing_expiration_date": "20261231"}