telmisartan

Generic: telmisartan

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

Drug Facts

Product Profile

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

telmisartan 40 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-292
Product ID 53746-292_77cf7b02-2f68-41ff-be0d-8ad569613822
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204415
Listing Expiration 2026-12-31
Marketing Start 2016-09-25

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 53746292
Hyphenated Format 53746-292

Supplemental Identifiers

RxCUI
205304 205305 282755
UPC
0353746291301 0353746293305 0353746292308
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
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (53746-292-30)
source: ndc

Packages (1)

53746-292-30 30 TABLET in 1 BOTTLE (53746-292-30)

Ingredients (1)

telmisartan (40 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": "77cf7b02-2f68-41ff-be0d-8ad569613822", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0353746291301", "0353746293305", "0353746292308"], "unii": ["U5SYW473RQ"], "rxcui": ["205304", "205305", "282755"], "spl_set_id": ["bf2dca37-ce9c-40e4-8ad6-b8186aa7fed1"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (53746-292-30)", "package_ndc": "53746-292-30", "marketing_start_date": "20160925"}], "brand_name": "Telmisartan", "product_id": "53746-292_77cf7b02-2f68-41ff-be0d-8ad569613822", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "53746-292", "generic_name": "Telmisartan", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Telmisartan", "active_ingredients": [{"name": "TELMISARTAN", "strength": "40 mg/1"}], "application_number": "ANDA204415", "marketing_category": "ANDA", "marketing_start_date": "20160925", "listing_expiration_date": "20261231"}