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United States · US · US:64693-002_6fa12acd-30da-4725-953d-68a30b52b66a
INOMAX
Orange BookUNIISPLATC R07AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerINO Therapeutics LLC
CountryUS (United States)
ATC codeR07AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1164693002011 CYLINDER in 1 CARTON (64693-002-01) / 353 L in 1 CYLINDER
- ndc1164693002021 CYLINDER in 1 CARTON (64693-002-02) / 1963 L in 1 CYLINDER
Annotations
UNII (FDA Substance ID)
31C4KY9ESH
NITRIC OXIDE
RxCUI 7442
Orange Book
N020845
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "31C4KY9ESH",
"rxcui": "7442",
"inchikey": "MWUXSHHQAYIFBG-UHFFFAOYSA-N",
"display_name": "NITRIC OXIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "RESPIRATORY (INHALATION)",
"spl_meta": {
"762b51be-1893-4cd1-9511-e645fc420d3a": {
"match": "brand_token",
"title": "INOMAX (NITRIC OXIDE) GAS [INO THERAPEUTICS LLC]",
"spl_version": "19",
"published_date": "2025-12-15"
}
},
"productid": "64693-002_6fa12acd-30da-4725-953d-68a30b52b66a",
"productndc": "64693-002",
"dosage_form": "GAS",
"orange_book": {
"appl_no": "020845",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Dec 23, 1999"
},
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "800PPM",
"product_no": "003",
"approval_date": "Dec 23, 1999"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "4880PPM",
"product_no": "004",
"approval_date": "Jan 17, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NITRIC OXIDE",
"proprietary_name": "INOMAX",
"active_ingred_unit": "mg/L",
"application_number": "NDA020845",
"marketing_category": "NDA",
"nonproprietary_name": "nitric oxide",
"start_marketing_date": "19991223",
"active_numerator_strength": ".98"
}Related drugs
Other records sharing ATC code R07AX01.
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