nitroglycerin

Generic: nitroglycerin

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitroglycerin
Generic Name nitroglycerin
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

nitroglycerin .4 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-639
Product ID 68462-639_76e69387-efc6-4816-972c-765cb260b34a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206391
Listing Expiration 2026-12-31
Marketing Start 2017-09-19

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 68462639
Hyphenated Format 68462-639

Supplemental Identifiers

RxCUI
198038 198039 198040
UPC
0368462638019 0368462639016 0368462640012
UNII
G59M7S0WS3
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 nitroglycerin (source: ndc)
Generic Name nitroglycerin (source: ndc)
Application Number ANDA206391 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • .4 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68462-639-01) / 100 TABLET in 1 BOTTLE
  • 4 BOTTLE in 1 CARTON (68462-639-45) / 25 TABLET in 1 BOTTLE (68462-639-25)
source: ndc

Packages (2)

68462-639-01 1 BOTTLE in 1 CARTON (68462-639-01) / 100 TABLET in 1 BOTTLE 68462-639-45 4 BOTTLE in 1 CARTON (68462-639-45) / 25 TABLET in 1 BOTTLE (68462-639-25)

Ingredients (1)

nitroglycerin (.4 mg/1)

Linked Drug Pages (1)

Nitroglycerin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "76e69387-efc6-4816-972c-765cb260b34a", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0368462638019", "0368462639016", "0368462640012"], "unii": ["G59M7S0WS3"], "rxcui": ["198038", "198039", "198040"], "spl_set_id": ["fa789d65-9407-4965-bd06-4457444b42be"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68462-639-01)  / 100 TABLET in 1 BOTTLE", "package_ndc": "68462-639-01", "marketing_start_date": "20170919"}, {"sample": false, "description": "4 BOTTLE in 1 CARTON (68462-639-45)  / 25 TABLET in 1 BOTTLE (68462-639-25)", "package_ndc": "68462-639-45", "marketing_start_date": "20170919"}], "brand_name": "Nitroglycerin", "product_id": "68462-639_76e69387-efc6-4816-972c-765cb260b34a", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "68462-639", "generic_name": "Nitroglycerin", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitroglycerin", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": ".4 mg/1"}], "application_number": "ANDA206391", "marketing_category": "ANDA", "marketing_start_date": "20170919", "listing_expiration_date": "20261231"}