Isordil Titradose

Generic: isosorbide dinitrate

Labeler: Bausch Health US LLC
NDC Directory HUMAN PRESCRIPTION DRUG NDA Active

Drug Facts

Product Profile

Brand Name Isordil Titradose
Generic Name isosorbide dinitrate
Labeler Bausch Health US LLC
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ISOSORBIDE DINITRATE 40 mg/1

Identifiers & Regulatory

Product NDC 0187-0192
Product ID 0187-0192_d8460fc0-476b-4a3a-b75b-11c87598ddcb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA012093
Listing Expiration 2027-12-31
Marketing Start 2013-04-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01870192
Hyphenated Format 0187-0192

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 Isordil Titradose (source: ndc)
Generic Name isosorbide dinitrate (source: ndc)
Application Number NDA012093 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0187-0192-01)
source: ndc

Packages (1)

0187-0192-01 100 TABLET in 1 BOTTLE (0187-0192-01)

Ingredients (1)

ISOSORBIDE DINITRATE (40 mg/1)

Linked Drug Pages (1)

Isordil Titradose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d8460fc0-476b-4a3a-b75b-11c87598ddcb", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0301870152012"], "unii": ["IA7306519N"], "rxcui": ["197840", "314055", "793872", "793873"], "spl_set_id": ["8ddd2577-311a-4967-bb67-ad72e2b76f83"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Bausch Health US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0187-0192-01)", "package_ndc": "0187-0192-01", "marketing_start_date": "20130401"}], "brand_name": "Isordil Titradose", "product_id": "0187-0192_d8460fc0-476b-4a3a-b75b-11c87598ddcb", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "0187-0192", "generic_name": "isosorbide dinitrate", "labeler_name": "Bausch Health US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isordil", "brand_name_suffix": "Titradose", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "40 mg/1"}], "application_number": "NDA012093", "marketing_category": "NDA", "marketing_start_date": "20130401", "listing_expiration_date": "20271231"}