telmisartan

Generic: telmisartan

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan
Generic Name telmisartan
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telmisartan 80 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-201
Product ID 68462-201_7e08eda5-be87-4e09-ae4e-880a18aa7a0b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090032
Listing Expiration 2027-12-31
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 68462201
Hyphenated Format 68462-201

Supplemental Identifiers

RxCUI
205304 205305 282755
UPC
0368462199305 0368462200308 0368462201305
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 ANDA090032 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68462-201-01)
  • 3 BLISTER PACK in 1 CARTON (68462-201-13) / 10 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (68462-201-30)
  • 4 BLISTER PACK in 1 CARTON (68462-201-78) / 10 TABLET in 1 BLISTER PACK
  • 90 TABLET in 1 BOTTLE (68462-201-90)
source: ndc

Packages (5)

68462-201-01 100 TABLET in 1 BOTTLE (68462-201-01) 68462-201-13 3 BLISTER PACK in 1 CARTON (68462-201-13) / 10 TABLET in 1 BLISTER PACK 68462-201-30 30 TABLET in 1 BOTTLE (68462-201-30) 68462-201-78 4 BLISTER PACK in 1 CARTON (68462-201-78) / 10 TABLET in 1 BLISTER PACK 68462-201-90 90 TABLET in 1 BOTTLE (68462-201-90)

Ingredients (1)

telmisartan (80 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": "7e08eda5-be87-4e09-ae4e-880a18aa7a0b", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0368462199305", "0368462200308", "0368462201305"], "unii": ["U5SYW473RQ"], "rxcui": ["205304", "205305", "282755"], "spl_set_id": ["c6eb489d-2946-4c14-839f-d4af761ead31"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68462-201-01)", "package_ndc": "68462-201-01", "marketing_start_date": "20140707"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (68462-201-13)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "68462-201-13", "marketing_start_date": "20140707"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68462-201-30)", "package_ndc": "68462-201-30", "marketing_start_date": "20201214"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (68462-201-78)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "68462-201-78", "marketing_start_date": "20201214"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68462-201-90)", "package_ndc": "68462-201-90", "marketing_start_date": "20240307"}], "brand_name": "Telmisartan", "product_id": "68462-201_7e08eda5-be87-4e09-ae4e-880a18aa7a0b", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "68462-201", "generic_name": "Telmisartan", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Telmisartan", "active_ingredients": [{"name": "TELMISARTAN", "strength": "80 mg/1"}], "application_number": "ANDA090032", "marketing_category": "ANDA", "marketing_start_date": "20140707", "listing_expiration_date": "20271231"}