telmisartan and amlodipine (0378-1077)

Drug Facts

Product Profile

Brand Name telmisartan and amlodipine

Generic Name telmisartan and amlodipine

Labeler mylan pharmaceuticals inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-1077

Product ID 0378-1077_c4f4323d-671d-478b-b088-008530932cee

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202516

Listing Expiration 2026-12-31

Marketing Start 2014-09-19

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 03781077

Hyphenated Format 0378-1077

Supplemental Identifiers

RxCUI

876514 876519 876524 876529

UPC

0303781075930 0303781076937 0303781078931 0303781077934

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 ANDA202516 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
80 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE, PLASTIC (0378-1077-93)

source: ndc

Packages (1)

0378-1077-93 30 TABLET in 1 BOTTLE, PLASTIC (0378-1077-93)

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": "c4f4323d-671d-478b-b088-008530932cee", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0303781075930", "0303781076937", "0303781078931", "0303781077934"], "unii": ["864V2Q084H", "U5SYW473RQ"], "rxcui": ["876514", "876519", "876524", "876529"], "spl_set_id": ["ca60a4d5-ace7-4889-94ee-e2265fd63811"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (0378-1077-93)", "package_ndc": "0378-1077-93", "marketing_start_date": "20140919"}], "brand_name": "Telmisartan and Amlodipine", "product_id": "0378-1077_c4f4323d-671d-478b-b088-008530932cee", "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": "0378-1077", "generic_name": "telmisartan and amlodipine", "labeler_name": "Mylan Pharmaceuticals Inc.", "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": "ANDA202516", "marketing_category": "ANDA", "marketing_start_date": "20140919", "listing_expiration_date": "20261231"}