telmisartan

Generic: telmisartan

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan
Generic Name telmisartan
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telmisartan 80 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-951
Product ID 63187-951_8de923a7-5488-4e04-8c58-37a3d5355d00
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205150
Listing Expiration 2026-12-31
Marketing Start 2016-06-12

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 63187951
Hyphenated Format 63187-951

Supplemental Identifiers

RxCUI
205305
UNII
U5SYW473RQ
NUI
N0000000070 N0000175561

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 ANDA205150 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (63187-951-30)
  • 60 TABLET in 1 BOTTLE (63187-951-60)
  • 90 TABLET in 1 BOTTLE (63187-951-90)
source: ndc

Packages (3)

63187-951-30 30 TABLET in 1 BOTTLE (63187-951-30) 63187-951-60 60 TABLET in 1 BOTTLE (63187-951-60) 63187-951-90 90 TABLET in 1 BOTTLE (63187-951-90)

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": "8de923a7-5488-4e04-8c58-37a3d5355d00", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["U5SYW473RQ"], "rxcui": ["205305"], "spl_set_id": ["593a53a4-91bc-4e4a-aeff-08fc2efe3dd4"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-951-30)", "package_ndc": "63187-951-30", "marketing_start_date": "20180101"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-951-60)", "package_ndc": "63187-951-60", "marketing_start_date": "20180101"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63187-951-90)", "package_ndc": "63187-951-90", "marketing_start_date": "20180101"}], "brand_name": "telmisartan", "product_id": "63187-951_8de923a7-5488-4e04-8c58-37a3d5355d00", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "63187-951", "generic_name": "telmisartan", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "telmisartan", "active_ingredients": [{"name": "TELMISARTAN", "strength": "80 mg/1"}], "application_number": "ANDA205150", "marketing_category": "ANDA", "marketing_start_date": "20160612", "listing_expiration_date": "20261231"}