inomax
Generic: nitric oxide
Labeler: ino therapeutics llcDrug Facts
Product Profile
Brand Name
inomax
Generic Name
nitric oxide
Labeler
ino therapeutics llc
Dosage Form
GAS
Routes
Active Ingredients
nitric oxide 6 mg/L
Manufacturer
Identifiers & Regulatory
Product NDC
64693-003
Product ID
64693-003_6fa12acd-30da-4725-953d-68a30b52b66a
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
NDA
Application Number
NDA020845
Listing Expiration
2026-12-31
Marketing Start
2023-01-17
Pharmacologic Class
Established (EPC)
Physiologic Effect
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
64693003
Hyphenated Format
64693-003
Supplemental Identifiers
RxCUI
UNII
NUI
Packaging Origin
Original Packager
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
inomax (source: ndc)
Generic Name
nitric oxide (source: ndc)
Application Number
NDA020845 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 6 mg/L
Packaging
- 78 L in 1 CYLINDER (64693-003-01)
Packages (1)
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "6fa12acd-30da-4725-953d-68a30b52b66a", "openfda": {"nui": ["N0000009909", "N0000175940"], "unii": ["31C4KY9ESH"], "rxcui": ["582608", "827693"], "spl_set_id": ["762b51be-1893-4cd1-9511-e645fc420d3a"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Vasodilator [EPC]"], "manufacturer_name": ["INO Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "78 L in 1 CYLINDER (64693-003-01)", "package_ndc": "64693-003-01", "marketing_start_date": "20230117"}], "brand_name": "INOMAX", "product_id": "64693-003_6fa12acd-30da-4725-953d-68a30b52b66a", "dosage_form": "GAS", "pharm_class": ["Vasodilation [PE]", "Vasodilator [EPC]"], "product_ndc": "64693-003", "generic_name": "nitric oxide", "labeler_name": "INO Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INOMAX", "active_ingredients": [{"name": "NITRIC OXIDE", "strength": "6 mg/L"}], "application_number": "NDA020845", "marketing_category": "NDA", "marketing_start_date": "20230117", "listing_expiration_date": "20261231"}