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United States · US · US:69344-144_6ec8c9cf-7780-4bb1-8233-8a4e28ab43f0
Sprix
In shortageOrange BookUNIISPLATC M01AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZyla Life Sciences US LLC
CountryUS (United States)
ATC codeM01AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1169344144435 CARTON in 1 CARTON (69344-144-43) / 1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)
- ndc1169344144531 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)
Annotations
UNII (FDA Substance ID)
4EVE5946BQ
KETOROLAC TROMETHAMINE
RxCUI 28200
Orange Book
N022382
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ketorolac Tromethamine Injection
Raw payload (JSON)
{
"unii": {
"unii": "4EVE5946BQ",
"rxcui": "28200",
"inchikey": "BWHLPLXXIDYSNW-UHFFFAOYSA-N",
"display_name": "KETOROLAC TROMETHAMINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "NASAL",
"spl_meta": {
"97005a1c-167e-4676-bae7-e49b38c36f9e": {
"match": "brand_token",
"title": "SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [ZYLA LIFE SCIENCES US LLC]",
"spl_version": "14",
"published_date": "2024-12-09"
}
},
"productid": "69344-144_6ec8c9cf-7780-4bb1-8233-8a4e28ab43f0",
"productndc": "69344-144",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "022382",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "15.75MG/SPRAY",
"product_no": "001",
"approval_date": "May 14, 2010"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "KETOROLAC TROMETHAMINE",
"shortage_reason": "Ketorolac Tromethamine Injection",
"shortage_status": "current",
"proprietary_name": "Sprix",
"active_ingred_unit": "mg/1",
"application_number": "NDA022382",
"marketing_category": "NDA",
"nonproprietary_name": "ketorolac tromethamine",
"start_marketing_date": "20110426",
"active_numerator_strength": "15.75"
}Related drugs
Other records sharing ATC code M01AB.
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