Zimhi
These highlights do not include all the information needed to use ZIMHI safely and effectively. See full prescribing information for ZIMHI. ZIMHI (naloxone hydrochloride injection) for intramuscular or subcutaneous use Initial U.S. Approval: 1971
Approved
Approval ID
52e49022-9172-4da3-ba83-5995cacca9fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 29, 2022
Manufacturers
FDA
USWM, LLC
DUNS: 117542566
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NALOXONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code78670-140
Application NumberNDA212854
Product Classification
M
Marketing Category
C73594
G
Generic Name
NALOXONE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateOctober 28, 2021
FDA Product Classification
INGREDIENTS (4)
sodium chlorideInactive
Quantity: 4.17 mg in 0.5 mL
Code: 451W47IQ8X
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
NALOXONE HYDROCHLORIDEActive
Quantity: 5 mg in 0.5 mL
Code: F850569PQR
Classification: ACTIB