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United States · US · US:0404-9880_66dc4477-9189-4ff8-b778-8ceb17a50802
KETALAR
In shortageOrange BookUNIISPLATC N01AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHenry Schein, Inc
CountryUS (United States)
ATC codeN01AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104049880201 VIAL in 1 BAG (0404-9880-20) / 20 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
O18YUO0I83
KETAMINE HYDROCHLORIDE
RxCUI 203184
Orange Book
N016812
APAPAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ketamine Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "O18YUO0I83",
"rxcui": "203184",
"inchikey": "VCMGMSHEPQENPE-UHFFFAOYSA-N",
"display_name": "KETAMINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"14e8f864-8b8a-4e7e-8439-e510d3107063": {
"match": "brand_token",
"title": "KETALAR (KETAMINE HYDROCHLORIDE) INJECTION [PAR HEALTH USA, LLC]",
"spl_version": "33",
"published_date": "2026-03-26"
}
},
"productid": "0404-9880_66dc4477-9189-4ff8-b778-8ceb17a50802",
"productndc": "0404-9880",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "016812",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "EQ 10MG BASE/ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "EQ 50MG BASE/ML",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "EQ 100MG BASE/ML",
"product_no": "003",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "KETAMINE HYDROCHLORIDE",
"shortage_reason": "Ketamine Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "KETALAR",
"active_ingred_unit": "mg/mL",
"application_number": "NDA016812",
"marketing_category": "NDA",
"nonproprietary_name": "ketamine hydrochloride",
"start_marketing_date": "20220111",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N01AX03.
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