telmisartan

Generic: telmisartan

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

Drug Facts

Product Profile

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

telmisartan 80 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3798
Product ID 70518-3798_3afc65d5-4d8f-d1c5-e063-6294a90a41d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205150
Listing Expiration 2026-12-31
Marketing Start 2023-07-18

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 705183798
Hyphenated Format 70518-3798

Supplemental Identifiers

RxCUI
205305
UNII
U5SYW473RQ
NUI
N0000000070 N0000175561

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
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (70518-3798-0)
source: ndc

Packages (1)

70518-3798-0 30 TABLET in 1 BOTTLE (70518-3798-0)

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": "3afc65d5-4d8f-d1c5-e063-6294a90a41d6", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["U5SYW473RQ"], "rxcui": ["205305"], "spl_set_id": ["09d31eee-cd22-4918-a889-3eb4d2969525"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (70518-3798-0)", "package_ndc": "70518-3798-0", "marketing_start_date": "20230718"}], "brand_name": "telmisartan", "product_id": "70518-3798_3afc65d5-4d8f-d1c5-e063-6294a90a41d6", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "70518-3798", "generic_name": "telmisartan", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "telmisartan", "active_ingredients": [{"name": "TELMISARTAN", "strength": "80 mg/1"}], "application_number": "ANDA205150", "marketing_category": "ANDA", "marketing_start_date": "20230718", "listing_expiration_date": "20261231"}