telmisartan

Generic: telmisartan

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan
Generic Name telmisartan
Labeler solco healthcare us, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telmisartan 40 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-284
Product ID 43547-284_98f95e17-f88b-4f47-b4bb-5db8f93793f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207882
Listing Expiration 2027-12-31
Marketing Start 2017-08-20

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 43547284
Hyphenated Format 43547-284

Supplemental Identifiers

RxCUI
205304 205305 282755
UPC
0343547285036 0343547284039 0343547283032
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 ANDA207882 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (43547-284-03)
  • 90 TABLET in 1 BOTTLE (43547-284-09)
  • 500 TABLET in 1 BOTTLE (43547-284-50)
source: ndc

Packages (3)

43547-284-03 30 TABLET in 1 BOTTLE (43547-284-03) 43547-284-09 90 TABLET in 1 BOTTLE (43547-284-09) 43547-284-50 500 TABLET in 1 BOTTLE (43547-284-50)

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": "98f95e17-f88b-4f47-b4bb-5db8f93793f7", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0343547285036", "0343547284039", "0343547283032"], "unii": ["U5SYW473RQ"], "rxcui": ["205304", "205305", "282755"], "spl_set_id": ["77442f0b-b522-4b19-ac1f-f0ce8576f0be"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43547-284-03)", "package_ndc": "43547-284-03", "marketing_start_date": "20170820"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43547-284-09)", "package_ndc": "43547-284-09", "marketing_start_date": "20170820"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43547-284-50)", "package_ndc": "43547-284-50", "marketing_start_date": "20170820"}], "brand_name": "Telmisartan", "product_id": "43547-284_98f95e17-f88b-4f47-b4bb-5db8f93793f7", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "43547-284", "generic_name": "Telmisartan", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Telmisartan", "active_ingredients": [{"name": "TELMISARTAN", "strength": "40 mg/1"}], "application_number": "ANDA207882", "marketing_category": "ANDA", "marketing_start_date": "20170820", "listing_expiration_date": "20271231"}