telmisartan

Generic: telmisartan

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan
Generic Name telmisartan
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telmisartan 40 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-483
Product ID 67877-483_3176efce-402d-3398-e063-6294a90a2f27
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205150
Listing Expiration 2026-12-31
Marketing Start 2016-06-12

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 67877483
Hyphenated Format 67877-483

Supplemental Identifiers

RxCUI
205304 205305 282755
UPC
0367877482309 0367877484303 0367877483306
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 ANDA205150 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (67877-483-05)
  • 30 TABLET in 1 BOTTLE (67877-483-30)
  • 90 TABLET in 1 BOTTLE (67877-483-90)
source: ndc

Packages (3)

67877-483-05 500 TABLET in 1 BOTTLE (67877-483-05) 67877-483-30 30 TABLET in 1 BOTTLE (67877-483-30) 67877-483-90 90 TABLET in 1 BOTTLE (67877-483-90)

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": "3176efce-402d-3398-e063-6294a90a2f27", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0367877482309", "0367877484303", "0367877483306"], "unii": ["U5SYW473RQ"], "rxcui": ["205304", "205305", "282755"], "spl_set_id": ["29bddc43-2809-4e1f-ae35-2865e15e9bb6"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (67877-483-05)", "package_ndc": "67877-483-05", "marketing_start_date": "20190725"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (67877-483-30)", "package_ndc": "67877-483-30", "marketing_start_date": "20190725"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (67877-483-90)", "package_ndc": "67877-483-90", "marketing_start_date": "20190725"}], "brand_name": "telmisartan", "product_id": "67877-483_3176efce-402d-3398-e063-6294a90a2f27", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "67877-483", "generic_name": "telmisartan", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "telmisartan", "active_ingredients": [{"name": "TELMISARTAN", "strength": "40 mg/1"}], "application_number": "ANDA205150", "marketing_category": "ANDA", "marketing_start_date": "20160612", "listing_expiration_date": "20261231"}