telmisartan

Generic: telmisartan

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan
Generic Name telmisartan
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telmisartan 20 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-867
Product ID 65862-867_eea7e7a7-9c01-4097-8e5c-ab1ad574acc8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206511
Listing Expiration 2026-12-31
Marketing Start 2015-09-03

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 65862867
Hyphenated Format 65862-867

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 ANDA206511 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (65862-867-03) / 10 TABLET in 1 BLISTER PACK (65862-867-10)
  • 30 TABLET in 1 BOTTLE (65862-867-30)
source: ndc

Packages (2)

65862-867-03 3 BLISTER PACK in 1 CARTON (65862-867-03) / 10 TABLET in 1 BLISTER PACK (65862-867-10) 65862-867-30 30 TABLET in 1 BOTTLE (65862-867-30)

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": "eea7e7a7-9c01-4097-8e5c-ab1ad574acc8", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["U5SYW473RQ"], "rxcui": ["205304", "205305", "282755"], "spl_set_id": ["fef6532d-438a-435e-a61f-216dd8551339"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-867-03)  / 10 TABLET in 1 BLISTER PACK (65862-867-10)", "package_ndc": "65862-867-03", "marketing_start_date": "20150903"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (65862-867-30)", "package_ndc": "65862-867-30", "marketing_start_date": "20190603"}], "brand_name": "Telmisartan", "product_id": "65862-867_eea7e7a7-9c01-4097-8e5c-ab1ad574acc8", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "65862-867", "generic_name": "Telmisartan", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Telmisartan", "active_ingredients": [{"name": "TELMISARTAN", "strength": "20 mg/1"}], "application_number": "ANDA206511", "marketing_category": "ANDA", "marketing_start_date": "20150903", "listing_expiration_date": "20261231"}