telmisartan

Generic: telmisartan

Labeler: chartwell rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan
Generic Name telmisartan
Labeler chartwell rx, llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telmisartan 80 mg/1

Manufacturer
Chartwell RX, LLC.

Identifiers & Regulatory

Product NDC 62135-537
Product ID 62135-537_459ee4aa-32df-2119-e063-6294a90a0e7a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078710
Listing Expiration 2026-12-31
Marketing Start 2020-11-23

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 62135537
Hyphenated Format 62135-537

Supplemental Identifiers

RxCUI
205304 205305 282755
UPC
0362135535308 0362135536305 0362135537302
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 ANDA078710 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (62135-537-30)
source: ndc

Packages (1)

62135-537-30 30 TABLET in 1 BOTTLE (62135-537-30)

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": "459ee4aa-32df-2119-e063-6294a90a0e7a", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0362135535308", "0362135536305", "0362135537302"], "unii": ["U5SYW473RQ"], "rxcui": ["205304", "205305", "282755"], "spl_set_id": ["beaaf383-730f-4411-b5e7-15c32b53a338"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Chartwell RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (62135-537-30)", "package_ndc": "62135-537-30", "marketing_start_date": "20230308"}], "brand_name": "TELMISARTAN", "product_id": "62135-537_459ee4aa-32df-2119-e063-6294a90a0e7a", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "62135-537", "generic_name": "TELMISARTAN", "labeler_name": "Chartwell RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TELMISARTAN", "active_ingredients": [{"name": "TELMISARTAN", "strength": "80 mg/1"}], "application_number": "ANDA078710", "marketing_category": "ANDA", "marketing_start_date": "20201123", "listing_expiration_date": "20261231"}