nitroglycerin

Generic: nitroglycerin

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

Drug Facts

Product Profile

Brand Name nitroglycerin
Generic Name nitroglycerin
Labeler cosette pharmaceuticals, inc.
Dosage Form OINTMENT
Routes
RECTAL
Active Ingredients

nitroglycerin 4 mg/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0564
Product ID 0713-0564_11e6d0dd-d89a-7551-e063-6394a90a16ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216103
Listing Expiration 2026-12-31
Marketing Start 2024-02-23

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 07130564
Hyphenated Format 0713-0564

Supplemental Identifiers

RxCUI
1114466
UPC
0307130564311
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 ANDA216103 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0713-0564-31) / 30 g in 1 TUBE
source: ndc

Packages (1)

0713-0564-31 1 TUBE in 1 CARTON (0713-0564-31) / 30 g in 1 TUBE

Ingredients (1)

nitroglycerin (4 mg/g)

Linked Drug Pages (1)

NITROGLYCERIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "11e6d0dd-d89a-7551-e063-6394a90a16ce", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0307130564311"], "unii": ["G59M7S0WS3"], "rxcui": ["1114466"], "spl_set_id": ["ac908e70-9425-4e9c-8c67-7b2882b40204"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0713-0564-31)  / 30 g in 1 TUBE", "package_ndc": "0713-0564-31", "marketing_start_date": "20240223"}], "brand_name": "NITROGLYCERIN", "product_id": "0713-0564_11e6d0dd-d89a-7551-e063-6394a90a16ce", "dosage_form": "OINTMENT", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "0713-0564", "generic_name": "nitroglycerin", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NITROGLYCERIN", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": "4 mg/g"}], "application_number": "ANDA216103", "marketing_category": "ANDA", "marketing_start_date": "20240223", "listing_expiration_date": "20261231"}