telmisartan and amlodipine (46708-186)

Drug Facts

Product Profile

Brand Name telmisartan and amlodipine

Generic Name telmisartan and amlodipine

Labeler alembic pharmaceuticals limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

amlodipine besylate 5 mg/1, telmisartan 80 mg/1

Manufacturer

Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-186

Product ID 46708-186_f0d9160e-9405-435e-9f36-75c537267221

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205234

Listing Expiration 2026-12-31

Marketing Start 2016-11-22

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 46708186

Hyphenated Format 46708-186

Supplemental Identifiers

RxCUI

876514 876519 876524 876529

UPC

0346708185084 0346708187064 0346708184087 0346708186067

UNII

864V2Q084H 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 and amlodipine (source: ndc)

Generic Name telmisartan and amlodipine (source: ndc)

Application Number ANDA205234 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
80 mg/1

source: ndc

Packaging

60 BLISTER PACK in 1 CARTON (46708-186-06) / 6 TABLET in 1 BLISTER PACK

source: ndc

Packages (1)

46708-186-06 60 BLISTER PACK in 1 CARTON (46708-186-06) / 6 TABLET in 1 BLISTER PACK

Ingredients (2)

amlodipine besylate (5 mg/1) telmisartan (80 mg/1)

Linked Drug Pages (1)

Telmisartan and Amlodipine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "f0d9160e-9405-435e-9f36-75c537267221", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0346708185084", "0346708187064", "0346708184087", "0346708186067"], "unii": ["864V2Q084H", "U5SYW473RQ"], "rxcui": ["876514", "876519", "876524", "876529"], "spl_set_id": ["15b438b4-4874-43f4-a50a-4e6f3e5530ac"], "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": "60 BLISTER PACK in 1 CARTON (46708-186-06)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "46708-186-06", "marketing_start_date": "20161122"}], "brand_name": "Telmisartan and Amlodipine", "product_id": "46708-186_f0d9160e-9405-435e-9f36-75c537267221", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "46708-186", "generic_name": "Telmisartan and Amlodipine", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Telmisartan and Amlodipine", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "TELMISARTAN", "strength": "80 mg/1"}], "application_number": "ANDA205234", "marketing_category": "ANDA", "marketing_start_date": "20161122", "listing_expiration_date": "20261231"}