Acetaminophen
These highlights do not include all the information needed to use, see full prescribing information for and Initial U.S. Approval. See full prescribing information for ACETAMINOPHEN injection for intravenous use. ACETAMINOPHEN Injection for intravenous use Initial U.S. Approval: 1951
Approved
Approval ID
adeebc6c-c82f-40dc-b813-1b02244984ce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 13, 2023
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 Code55579-110
Application NumberANDA202605
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACETAMINOPHEN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 13, 2023
FDA Product Classification
INGREDIENTS (4)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
ACETAMINOPHENActive
Quantity: 1000 mg in 100 mL
Code: 362O9ITL9D
Classification: ACTIB
Drug Labeling Information
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 2/13/2023
RECENT MAJOR CHANGES
Dosage and Administration (2.5) 11/2016
Dosage and Administration (2.4) 01/2017