MKH Dose Pack
Approved
Approval ID
835ea393-6860-5875-e053-2a91aa0ac9c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 5, 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 - Hydroxyzine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71384-420
Product Classification
G
Generic Name
Midazolam - Ketamine HCl - Hydroxyzine HCl
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMarch 5, 2019
FDA Product Classification
INGREDIENTS (3)
KETAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: O18YUO0I83
Classification: ACTIM
MIDAZOLAMActive
Quantity: 3 mg in 1 1
Code: R60L0SM5BC
Classification: ACTIB
HYDROXYZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 76755771U3
Classification: ACTIB