telmisartan

Generic: telmisartan

Labeler: jubilant cadista pharmacuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan
Generic Name telmisartan
Labeler jubilant cadista pharmacuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telmisartan 40 mg/1

Manufacturer
Jubilant Cadista Pharmacuticals Inc.

Identifiers & Regulatory

Product NDC 59746-440
Product ID 59746-440_482ba8bc-d601-48d8-9d50-8fa4d2c255fe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204164
Listing Expiration 2026-12-31
Marketing Start 2016-08-22

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 59746440
Hyphenated Format 59746-440

Supplemental Identifiers

RxCUI
205304 205305 282755
UPC
0359746440121
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 ANDA204164 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (59746-440-32) / 10 TABLET in 1 BLISTER PACK (59746-440-12)
source: ndc

Packages (1)

Ingredients (1)

telmisartan (40 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "482ba8bc-d601-48d8-9d50-8fa4d2c255fe", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0359746440121"], "unii": ["U5SYW473RQ"], "rxcui": ["205304", "205305", "282755"], "spl_set_id": ["e1a907a7-fad9-a860-8639-4c6136c85734"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Jubilant Cadista Pharmacuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (59746-440-32)  / 10 TABLET in 1 BLISTER PACK (59746-440-12)", "package_ndc": "59746-440-32", "marketing_start_date": "20160822"}], "brand_name": "Telmisartan", "product_id": "59746-440_482ba8bc-d601-48d8-9d50-8fa4d2c255fe", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "59746-440", "generic_name": "Telmisartan", "labeler_name": "Jubilant Cadista Pharmacuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Telmisartan", "active_ingredients": [{"name": "TELMISARTAN", "strength": "40 mg/1"}], "application_number": "ANDA204164", "marketing_category": "ANDA", "marketing_start_date": "20160822", "listing_expiration_date": "20261231"}