isosorbide dinitrate

Generic: isosorbide dinitrate

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide dinitrate
Generic Name isosorbide dinitrate
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isosorbide dinitrate 40 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-9593
Product ID 63629-9593_d39aa53f-52e2-45c6-93de-150f47e14bbf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211290
Listing Expiration 2026-12-31
Marketing Start 2021-12-21

Pharmacologic Class

Established (EPC)
nitrate vasodilator [epc]
Chemical Structure
nitrates [cs]
Physiologic Effect
vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636299593
Hyphenated Format 63629-9593

Supplemental Identifiers

RxCUI
197840
UNII
IA7306519N
NUI
N0000175415 M0014874 N0000009909

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 isosorbide dinitrate (source: ndc)
Generic Name isosorbide dinitrate (source: ndc)
Application Number ANDA211290 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (63629-9593-1)
source: ndc

Packages (1)

63629-9593-1 100 TABLET in 1 BOTTLE (63629-9593-1)

Ingredients (1)

isosorbide dinitrate (40 mg/1)

Linked Drug Pages (1)

Isosorbide Dinitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d39aa53f-52e2-45c6-93de-150f47e14bbf", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["IA7306519N"], "rxcui": ["197840"], "spl_set_id": ["73a1e6c0-71d0-4ba1-bbca-c067479e487d"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (63629-9593-1)", "package_ndc": "63629-9593-1", "marketing_start_date": "20211221"}], "brand_name": "Isosorbide Dinitrate", "product_id": "63629-9593_d39aa53f-52e2-45c6-93de-150f47e14bbf", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "63629-9593", "generic_name": "Isosorbide Dinitrate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Dinitrate", "active_ingredients": [{"name": "ISOSORBIDE DINITRATE", "strength": "40 mg/1"}], "application_number": "ANDA211290", "marketing_category": "ANDA", "marketing_start_date": "20211221", "listing_expiration_date": "20261231"}