telmisartan

Generic: telmisartan

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan
Generic Name telmisartan
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telmisartan 20 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-2920
Product ID 0378-2920_0bdc0a35-e9b0-41a9-96f8-5b85497298f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202397
Listing Expiration 2026-12-31
Marketing Start 2014-07-07

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 03782920
Hyphenated Format 0378-2920

Supplemental Identifiers

RxCUI
205304 205305 282755
UPC
0303782921939 0303782920932 0303782922936
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 ANDA202397 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (0378-2920-77)
  • 30 TABLET in 1 BOTTLE, PLASTIC (0378-2920-93)
source: ndc

Packages (2)

0378-2920-77 90 TABLET in 1 BOTTLE, PLASTIC (0378-2920-77) 0378-2920-93 30 TABLET in 1 BOTTLE, PLASTIC (0378-2920-93)

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": "0bdc0a35-e9b0-41a9-96f8-5b85497298f9", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0303782921939", "0303782920932", "0303782922936"], "unii": ["U5SYW473RQ"], "rxcui": ["205304", "205305", "282755"], "spl_set_id": ["c3658bc8-1524-43db-930e-66f9ac01b808"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (0378-2920-77)", "package_ndc": "0378-2920-77", "marketing_start_date": "20140707"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (0378-2920-93)", "package_ndc": "0378-2920-93", "marketing_start_date": "20140707"}], "brand_name": "Telmisartan", "product_id": "0378-2920_0bdc0a35-e9b0-41a9-96f8-5b85497298f9", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "0378-2920", "generic_name": "telmisartan", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Telmisartan", "active_ingredients": [{"name": "TELMISARTAN", "strength": "20 mg/1"}], "application_number": "ANDA202397", "marketing_category": "ANDA", "marketing_start_date": "20140707", "listing_expiration_date": "20261231"}