telmisartan

Generic: telmisartan

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan
Generic Name telmisartan
Labeler avkare
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telmisartan 40 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-791
Product ID 42291-791_4875af35-46c7-d9e6-e063-6394a90ab93d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204415
Listing Expiration 2027-12-31
Marketing Start 2017-12-20

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 42291791
Hyphenated Format 42291-791

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 ANDA204415 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (42291-791-30)
source: ndc

Packages (1)

42291-791-30 30 TABLET in 1 BOTTLE (42291-791-30)

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": "4875af35-46c7-d9e6-e063-6394a90ab93d", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["U5SYW473RQ"], "rxcui": ["205304", "205305", "282755"], "spl_set_id": ["71902893-55da-4286-8b25-b528641489ef"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (42291-791-30)", "package_ndc": "42291-791-30", "marketing_start_date": "20171220"}], "brand_name": "Telmisartan", "product_id": "42291-791_4875af35-46c7-d9e6-e063-6394a90ab93d", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "42291-791", "generic_name": "Telmisartan", "labeler_name": "AvKARE", "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": "20171220", "listing_expiration_date": "20271231"}