FDA.reportPublic FDA data

Acetaminophen injection

Manufacturer
Zydus Lifesciences Limited
Effective date
2022-11-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:50:37

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure1 sections

Label contents#

Full prescribing information#

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
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
carton label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1759ACETAMINOPHEN INJECTION [ZYDUS LIFESCIENCES LIMITED]1Unmatched20241103_a7a402cf-15ef-4b40-9084-3d9d8abe116e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-175970771-1759-1, 70771-1759-6, 70771-1759-9, 70771-1759-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
MANNITOL3OWL53L36AIACT
CYSTEINE HYDROCHLORIDEZT934N0X4WIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROCHLORIC ACIDQTT17582CBIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e6bdeff4-08de-44ab-8b09-0cfff9832014a7a402cf-15ef-4b40-9084-3d9d8abe116e2025-05-31Exact identifier
spl set id: a7a402cf-15ef-4b40-9084-3d9d8abe116e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.