isosorbide mononitrate

Generic: isosorbide mononitrate

Labeler: shandong new time pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide mononitrate
Generic Name isosorbide mononitrate
Labeler shandong new time pharmaceutical co., ltd.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

isosorbide mononitrate 60 mg/1

Manufacturer
Shandong New Time Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 42677-306
Product ID 42677-306_47b286d2-bbaf-75ff-e063-6294a90a6de7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214115
Listing Expiration 2027-12-31
Marketing Start 2024-02-08

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 42677306
Hyphenated Format 42677-306

Supplemental Identifiers

RxCUI
311196 317110 353538
UPC
0342677306017 0342677307021 0342677307014 0342677305010
UNII
LX1OH63030
NUI
N0000175415 M0014874 N0000009909

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 isosorbide mononitrate (source: ndc)
Generic Name isosorbide mononitrate (source: ndc)
Application Number ANDA214115 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42677-306-01)
source: ndc

Packages (1)

42677-306-01 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42677-306-01)

Ingredients (1)

isosorbide mononitrate (60 mg/1)

Linked Drug Pages (1)

Isosorbide Mononitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47b286d2-bbaf-75ff-e063-6294a90a6de7", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0342677306017", "0342677307021", "0342677307014", "0342677305010"], "unii": ["LX1OH63030"], "rxcui": ["311196", "317110", "353538"], "spl_set_id": ["cd953cfa-b6f5-4b82-afcc-52a57236b9d3"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Shandong New Time Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42677-306-01)", "package_ndc": "42677-306-01", "marketing_start_date": "20240208"}], "brand_name": "Isosorbide Mononitrate", "product_id": "42677-306_47b286d2-bbaf-75ff-e063-6294a90a6de7", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "42677-306", "generic_name": "Isosorbide Mononitrate", "labeler_name": "Shandong New Time Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosorbide Mononitrate", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "60 mg/1"}], "application_number": "ANDA214115", "marketing_category": "ANDA", "marketing_start_date": "20240208", "listing_expiration_date": "20271231"}