Acetaminophen by Zydus Lifesciences Limited Acetaminophen injection

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACETAMINOPHEN- acetaminophen injection 
Zydus Lifesciences Limited

----------

Acetaminophen injection

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

70771-1759-1

Acetaminophen injection

1000 mg/100 mL

(10 mg/mL)

For Intravenous Use Only

Rx only

100 mL Single-Dose Vial.

Doses less than 1000 mg require aseptic transfer to a separate container prior to dispensing. Discard unused portion.

vial label

70771-1759-7

Acetaminophen injection

1000 mg/100 mL

(10 mg/mL)

For Intravenous Use Only

Rx only

24 X 100 mL Single-Dose Vials.

Doses less than 1000 mg require aseptic transfer to a separate container prior to dispensing. Discard unused portion.

carton label
ACETAMINOPHEN 
acetaminophen injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70771-1759
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A)  
CYSTEINE HYDROCHLORIDE (UNII: ZT934N0X4W)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70771-1759-610 in 1 CARTON11/02/202403/25/2025
1NDC: 70771-1759-1100 mL in 1 VIAL; Type 0: Not a Combination Product
2NDC: 70771-1759-920 in 1 CARTON11/02/202403/25/2025
2NDC: 70771-1759-1100 mL in 1 VIAL; Type 0: Not a Combination Product
3NDC: 70771-1759-724 in 1 CARTON11/02/202403/25/2025
3NDC: 70771-1759-1100 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21646711/02/202405/31/2025
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited873671928MANUFACTURE(70771-1759) , ANALYSIS(70771-1759)

Revised: 5/2025
 

Trademark Results [Acetaminophen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACETAMINOPHEN
ACETAMINOPHEN
85615223 not registered Dead/Abandoned
General Merchandise importers and Expoters
2012-05-03

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.