MKO Melt Dose Pack
Approved
Approval ID
83491310-f848-ce3d-e053-2a91aa0aa906
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 4, 2019
Manufacturers
FDA
Imprimis NJOF, LLC
DUNS: 080431967
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Midazolam - Ketamine HCl - Ondansetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71384-410
Product Classification
G
Generic Name
Midazolam - Ketamine HCl - Ondansetron
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMarch 4, 2019
FDA Product Classification
INGREDIENTS (3)
MIDAZOLAMActive
Quantity: 3 mg in 1 1
Code: R60L0SM5BC
Classification: ACTIB
KETAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: O18YUO0I83
Classification: ACTIM
ONDANSETRON HYDROCHLORIDE ANHYDROUSActive
Quantity: 2 mg in 1 1
Code: 2999F27MAD
Classification: ACTIM
Drug Labeling Information
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 3/4/2019
Storage and Handling
Store at 20° to 25° C (68° to 77° F)