nisoldipine

Generic: nisoldipine

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

Drug Facts

Product Profile

Brand Name nisoldipine
Generic Name nisoldipine
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nisoldipine 25.5 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-2098
Product ID 0378-2098_492b9d76-acce-4813-8953-466f778ef404
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091001
Marketing Start 2011-01-28
Marketing End 2026-03-31

Pharmacologic Class

Established (EPC)
dihydropyridine calcium channel blocker [epc]
Mechanism of Action
calcium channel antagonists [moa]
Chemical Structure
dihydropyridines [cs]
Physiologic Effect
decreased blood pressure [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03782098
Hyphenated Format 0378-2098

Supplemental Identifiers

RxCUI
763519 763574 763589 790489
UPC
0303782099010 0303782097016 0303782096019 0303782098013
UNII
4I8HAB65SZ
NUI
N0000175421 M0006414 N0000000069 N0000178477

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 nisoldipine (source: ndc)
Generic Name nisoldipine (source: ndc)
Application Number ANDA091001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25.5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2098-01)
source: ndc

Packages (1)

0378-2098-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2098-01)

Ingredients (1)

nisoldipine (25.5 mg/1)

Linked Drug Pages (1)

Nisoldipine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "492b9d76-acce-4813-8953-466f778ef404", "openfda": {"nui": ["N0000175421", "M0006414", "N0000000069", "N0000178477"], "upc": ["0303782099010", "0303782097016", "0303782096019", "0303782098013"], "unii": ["4I8HAB65SZ"], "rxcui": ["763519", "763574", "763589", "790489"], "spl_set_id": ["00d506a4-74d6-4838-b008-3f9e7c017e08"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_pe": ["Decreased Blood Pressure [PE]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2098-01)", "package_ndc": "0378-2098-01", "marketing_end_date": "20260331", "marketing_start_date": "20110128"}], "brand_name": "Nisoldipine", "product_id": "0378-2098_492b9d76-acce-4813-8953-466f778ef404", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Decreased Blood Pressure [PE]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "0378-2098", "generic_name": "nisoldipine", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nisoldipine", "active_ingredients": [{"name": "NISOLDIPINE", "strength": "25.5 mg/1"}], "application_number": "ANDA091001", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20110128"}