telmisartan

Generic: telmisartan

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan
Generic Name telmisartan
Labeler alembic pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

telmisartan 20 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-608
Product ID 46708-608_ae0d2b4e-7cf3-481b-9fc7-002c00214a56
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202130
Listing Expiration 2026-12-31
Marketing Start 2016-06-25

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 46708608
Hyphenated Format 46708-608

Supplemental Identifiers

RxCUI
205304 205305 282755
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 ANDA202130 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 CARTON (46708-608-10)
  • 30 TABLET in 1 BOTTLE (46708-608-30)
  • 1000 TABLET in 1 BOTTLE (46708-608-91)
source: ndc

Packages (3)

46708-608-10 100 TABLET in 1 CARTON (46708-608-10) 46708-608-30 30 TABLET in 1 BOTTLE (46708-608-30) 46708-608-91 1000 TABLET in 1 BOTTLE (46708-608-91)

Ingredients (1)

telmisartan (20 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": "ae0d2b4e-7cf3-481b-9fc7-002c00214a56", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["U5SYW473RQ"], "rxcui": ["205304", "205305", "282755"], "spl_set_id": ["4be6575f-ea8d-4cd8-a49d-3d1c93f2621a"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 CARTON (46708-608-10)", "package_ndc": "46708-608-10", "marketing_start_date": "20160625"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (46708-608-30)", "package_ndc": "46708-608-30", "marketing_start_date": "20160625"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (46708-608-91)", "package_ndc": "46708-608-91", "marketing_start_date": "20160625"}], "brand_name": "Telmisartan", "product_id": "46708-608_ae0d2b4e-7cf3-481b-9fc7-002c00214a56", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "46708-608", "generic_name": "Telmisartan", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Telmisartan", "active_ingredients": [{"name": "TELMISARTAN", "strength": "20 mg/1"}], "application_number": "ANDA202130", "marketing_category": "ANDA", "marketing_start_date": "20160625", "listing_expiration_date": "20261231"}