telmisartan

Generic: telmisartan

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan
Generic Name telmisartan
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telmisartan 40 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-119
Product ID 33342-119_94abae59-69ec-482d-b4cf-285d502d82e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203986
Listing Expiration 2027-12-31
Marketing Start 2025-01-15

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 33342119
Hyphenated Format 33342-119

Supplemental Identifiers

RxCUI
205304 205305 282755
UPC
0333342120106 0333342119070 0333342118073 0333342119100 0333342120076
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 ANDA203986 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 CONTAINER (33342-119-07)
  • 90 TABLET in 1 CONTAINER (33342-119-10)
source: ndc

Packages (2)

33342-119-07 30 TABLET in 1 CONTAINER (33342-119-07) 33342-119-10 90 TABLET in 1 CONTAINER (33342-119-10)

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": "94abae59-69ec-482d-b4cf-285d502d82e7", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0333342120106", "0333342119070", "0333342118073", "0333342119100", "0333342120076"], "unii": ["U5SYW473RQ"], "rxcui": ["205304", "205305", "282755"], "spl_set_id": ["671d5a85-4146-43b4-9d7d-ca53268eb2a6"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 CONTAINER (33342-119-07)", "package_ndc": "33342-119-07", "marketing_start_date": "20250115"}, {"sample": false, "description": "90 TABLET in 1 CONTAINER (33342-119-10)", "package_ndc": "33342-119-10", "marketing_start_date": "20250115"}], "brand_name": "Telmisartan", "product_id": "33342-119_94abae59-69ec-482d-b4cf-285d502d82e7", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "33342-119", "generic_name": "Telmisartan", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Telmisartan", "active_ingredients": [{"name": "TELMISARTAN", "strength": "40 mg/1"}], "application_number": "ANDA203986", "marketing_category": "ANDA", "marketing_start_date": "20250115", "listing_expiration_date": "20271231"}