Acetaminophen injection

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

70771-1759-1

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.

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.

ACETAMINOPHEN
acetaminophen injection

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
MANNITOL (UNII: 3OWL53L36A)
CYSTEINE HYDROCHLORIDE (UNII: ZT934N0X4W)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1759-6	10 in 1 CARTON	11/02/2024	03/25/2025
1	NDC:70771-1759-1	100 mL in 1 VIAL; Type 0: Not a Combination Product
2	NDC:70771-1759-9	20 in 1 CARTON	11/02/2024	03/25/2025
2	NDC:70771-1759-1	100 mL in 1 VIAL; Type 0: Not a Combination Product
3	NDC:70771-1759-7	24 in 1 CARTON	11/02/2024	03/25/2025
3	NDC:70771-1759-1	100 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA216467	11/02/2024	05/31/2025

Labeler - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		873671928	MANUFACTURE(70771-1759) , ANALYSIS(70771-1759)

Revised: 5/2025

Document Id: e6bdeff4-08de-44ab-8b09-0cfff9832014

Set id: a7a402cf-15ef-4b40-9084-3d9d8abe116e

Version: 2

Effective Time: 20250531

Zydus Lifesciences Limited