nitroglycerin

Generic: nitroglycerin

Labeler: solco healthcare u.s., llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitroglycerin
Generic Name nitroglycerin
Labeler solco healthcare u.s., llc
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

nitroglycerin .4 mg/1

Manufacturer
Solco Healthcare U.S., LLC

Identifiers & Regulatory

Product NDC 43547-986
Product ID 43547-986_6624eac6-c803-45d1-ad99-8ffa6c5a5ac9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218583
Listing Expiration 2026-12-31
Marketing Start 2025-06-01

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 43547986
Hyphenated Format 43547-986

Supplemental Identifiers

RxCUI
198038 198039 198040
UPC
0343547986100 0343547987107 0343547985103 0343547986049
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 ANDA218583 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • .4 mg/1
source: ndc
Packaging
  • 4 BOTTLE in 1 CARTON (43547-986-04) / 25 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43547-986-10) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (2)

43547-986-04 4 BOTTLE in 1 CARTON (43547-986-04) / 25 TABLET in 1 BOTTLE 43547-986-10 1 BOTTLE in 1 CARTON (43547-986-10) / 100 TABLET in 1 BOTTLE

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": "6624eac6-c803-45d1-ad99-8ffa6c5a5ac9", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0343547986100", "0343547987107", "0343547985103", "0343547986049"], "unii": ["G59M7S0WS3"], "rxcui": ["198038", "198039", "198040"], "spl_set_id": ["61759752-dd07-4bed-8079-b578e3930519"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Solco Healthcare U.S., LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BOTTLE in 1 CARTON (43547-986-04)  / 25 TABLET in 1 BOTTLE", "package_ndc": "43547-986-04", "marketing_start_date": "20250601"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43547-986-10)  / 100 TABLET in 1 BOTTLE", "package_ndc": "43547-986-10", "marketing_start_date": "20250601"}], "brand_name": "Nitroglycerin", "product_id": "43547-986_6624eac6-c803-45d1-ad99-8ffa6c5a5ac9", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "43547-986", "generic_name": "Nitroglycerin", "labeler_name": "Solco Healthcare U.S., LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitroglycerin", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": ".4 mg/1"}], "application_number": "ANDA218583", "marketing_category": "ANDA", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}