nitroglycerin

Generic: nitroglycerin

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

Drug Facts

Product Profile

Brand Name nitroglycerin
Generic Name nitroglycerin
Labeler mylan pharmaceuticals inc.
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

nitroglycerin .1 mg/h

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-9102
Product ID 0378-9102_68d53366-0e2b-4370-a084-af17a1a88681
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074559
Listing Expiration 2026-12-31
Marketing Start 1998-06-18

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 03789102
Hyphenated Format 0378-9102

Supplemental Identifiers

RxCUI
486146 486148 486152 861657
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 ANDA074559 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/h
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (0378-9102-93) / 1 PATCH in 1 POUCH (0378-9102-16) / 14 h in 1 PATCH
source: ndc

Packages (1)

0378-9102-93 30 POUCH in 1 CARTON (0378-9102-93) / 1 PATCH in 1 POUCH (0378-9102-16) / 14 h in 1 PATCH

Ingredients (1)

nitroglycerin (.1 mg/h)

Linked Drug Pages (1)

Nitroglycerin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "68d53366-0e2b-4370-a084-af17a1a88681", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["G59M7S0WS3"], "rxcui": ["486146", "486148", "486152", "861657"], "spl_set_id": ["e98a2692-1cb9-4994-98d8-1d8d9ef1a256"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (0378-9102-93)  / 1 PATCH in 1 POUCH (0378-9102-16)  / 14 h in 1 PATCH", "package_ndc": "0378-9102-93", "marketing_start_date": "19980618"}], "brand_name": "Nitroglycerin", "product_id": "0378-9102_68d53366-0e2b-4370-a084-af17a1a88681", "dosage_form": "PATCH", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "0378-9102", "generic_name": "nitroglycerin", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitroglycerin", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": ".1 mg/h"}], "application_number": "ANDA074559", "marketing_category": "ANDA", "marketing_start_date": "19980618", "listing_expiration_date": "20261231"}