Acetaminophen
These highlights do not include all the information needed to use ACETAMINOPHEN INJECTION safely and effectively. See full prescribing information for ACETAMINOPHEN INJECTION.<BR><BR>ACETAMINOPHEN injection, for intravenous use only<BR>Initial U.S. Approval: 1951
Approved
Approval ID
188211b6-acc7-4257-a757-8e2d596ebbc3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 8, 2023
Manufacturers
FDA
Wockhardt USA LLC.
DUNS: 170508365
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 Code64679-600
Application NumberANDA205746
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 8, 2023
FDA Product Classification
INGREDIENTS (7)
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ACETAMINOPHENActive
Quantity: 10 mg in 1 mL
Code: 362O9ITL9D
Classification: ACTIB