Acetaminophen
These highlights do not include all the information needed to use ACETAMINOPHEN injection for intravenous use safely and effectively. See full prescribing information for ACETAMINOPHEN injection for intravenous use. ACETAMINOPHEN Injection for intravenous use Initial U.S. Approval: 1951
Approved
Approval ID
d92be8ae-3173-0a9d-e053-2995a90abc63
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2022
Manufacturers
FDA
Solupharm Pharmazeutische Erzeugnisse GmbH
DUNS: 316875129
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ACETAMINOPHEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55579-405
Application NumberANDA202605
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACETAMINOPHEN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 1, 2022
FDA Product Classification
INGREDIENTS (8)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
ACETAMINOPHENActive
Quantity: 10 mg in 1 mL
Code: 362O9ITL9D
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT