isosorbide mononitrate

Generic: isosorbide mononitrate

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

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler remedyrepack inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

isosorbide mononitrate 30 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-2956
Product ID 70518-2956_4ab9f8a1-dca0-d354-e063-6394a90ae775
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200270
Listing Expiration 2027-12-31
Marketing Start 2020-12-03

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 705182956
Hyphenated Format 70518-2956

Supplemental Identifiers

RxCUI
317110
UNII
LX1OH63030
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 mononitrate (source: ndc)
Generic Name isosorbide mononitrate (source: ndc)
Application Number ANDA200270 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2956-1)
source: ndc

Packages (1)

Ingredients (1)

isosorbide mononitrate (30 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4ab9f8a1-dca0-d354-e063-6394a90ae775", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["LX1OH63030"], "rxcui": ["317110"], "spl_set_id": ["d01d4f0f-5164-4ea3-b772-72b97961c6fb"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2956-1)", "package_ndc": "70518-2956-1", "marketing_start_date": "20241217"}], "brand_name": "ISOSORBIDE MONONITRATE", "product_id": "70518-2956_4ab9f8a1-dca0-d354-e063-6394a90ae775", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "70518-2956", "generic_name": "ISOSORBIDE MONONITRATE", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISOSORBIDE MONONITRATE", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "30 mg/1"}], "application_number": "ANDA200270", "marketing_category": "ANDA", "marketing_start_date": "20201203", "listing_expiration_date": "20271231"}