telmisartan and amlodipine

Generic: telmisartan and amlodipine

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

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 10 mg/1, telmisartan 80 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-1078
Product ID 0378-1078_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 03781078
Hyphenated Format 0378-1078

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
  • 10 mg/1
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (0378-1078-93)
source: ndc

Packages (1)

0378-1078-93 30 TABLET in 1 BOTTLE, PLASTIC (0378-1078-93)

Ingredients (2)

amlodipine besylate (10 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 (0378-1078-93)", "package_ndc": "0378-1078-93", "marketing_start_date": "20140919"}], "brand_name": "Telmisartan and Amlodipine", "product_id": "0378-1078_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": "0378-1078", "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": "10 mg/1"}, {"name": "TELMISARTAN", "strength": "80 mg/1"}], "application_number": "ANDA202516", "marketing_category": "ANDA", "marketing_start_date": "20140919", "listing_expiration_date": "20261231"}