telmisartan

Generic: telmisartan

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan
Generic Name telmisartan
Labeler micro labs limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telmisartan 80 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-228
Product ID 42571-228_f2aa8284-f86c-3425-e053-2995a90a6dc6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207016
Listing Expiration 2026-12-31
Marketing Start 2018-01-01

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 42571228
Hyphenated Format 42571-228

Supplemental Identifiers

RxCUI
205304 205305 282755
UPC
0342571228309 0342571226305 0342571227302
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 ANDA207016 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (42571-228-05)
  • 1000 TABLET in 1 BOTTLE (42571-228-10)
  • 10 BLISTER PACK in 1 CARTON (42571-228-11) / 10 TABLET in 1 BLISTER PACK (42571-228-32)
  • 30 TABLET in 1 BOTTLE (42571-228-30)
  • 3 TABLET in 1 CARTON (42571-228-41)
  • 90 TABLET in 1 BOTTLE (42571-228-90)
source: ndc

Packages (6)

42571-228-05 500 TABLET in 1 BOTTLE (42571-228-05) 42571-228-10 1000 TABLET in 1 BOTTLE (42571-228-10) 42571-228-11 10 BLISTER PACK in 1 CARTON (42571-228-11) / 10 TABLET in 1 BLISTER PACK (42571-228-32) 42571-228-30 30 TABLET in 1 BOTTLE (42571-228-30) 42571-228-41 3 TABLET in 1 CARTON (42571-228-41) 42571-228-90 90 TABLET in 1 BOTTLE (42571-228-90)

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": "f2aa8284-f86c-3425-e053-2995a90a6dc6", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0342571228309", "0342571226305", "0342571227302"], "unii": ["U5SYW473RQ"], "rxcui": ["205304", "205305", "282755"], "spl_set_id": ["d7c9bd41-9558-46e1-ab03-82cdf85db3fe"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (42571-228-05)", "package_ndc": "42571-228-05", "marketing_start_date": "20180101"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (42571-228-10)", "package_ndc": "42571-228-10", "marketing_start_date": "20180101"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (42571-228-11)  / 10 TABLET in 1 BLISTER PACK (42571-228-32)", "package_ndc": "42571-228-11", "marketing_start_date": "20180101"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (42571-228-30)", "package_ndc": "42571-228-30", "marketing_start_date": "20180101"}, {"sample": false, "description": "3 TABLET in 1 CARTON (42571-228-41)", "package_ndc": "42571-228-41", "marketing_start_date": "20180101"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (42571-228-90)", "package_ndc": "42571-228-90", "marketing_start_date": "20180101"}], "brand_name": "TELMISARTAN", "product_id": "42571-228_f2aa8284-f86c-3425-e053-2995a90a6dc6", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "42571-228", "generic_name": "Telmisartan", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TELMISARTAN", "active_ingredients": [{"name": "TELMISARTAN", "strength": "80 mg/1"}], "application_number": "ANDA207016", "marketing_category": "ANDA", "marketing_start_date": "20180101", "listing_expiration_date": "20261231"}