Acetaminophen

Product NDC
63323-434
11-digit product format
633230434
Labeler code
63323
Product ID
63323-434_be958bb9-95c1-4525-a145-f1372f08f978
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA204767
Marketing category
NDA
Marketing start
2020-12-06
Substance
ACETAMINOPHEN
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui483017

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-434-00Acetaminophen20 in 1 CASEINJECTION205
63323-434-41Acetaminophen100 mL in 1 BAGINJECTION1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-434ACETAMINOPHEN INJECTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20240427_a0cece43-256e-4adc-92f8-11a0f473bb83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483017acetaminophen 1000 MG in 100 ML InjectionPSNa0cece43-256e-4adc-92f8-11a0f473bb835
483017100 ML acetaminophen 10 MG/ML InjectionSCDa0cece43-256e-4adc-92f8-11a0f473bb835
483017100 ML APAP 10 MG/ML InjectionSYa0cece43-256e-4adc-92f8-11a0f473bb835
483017acetaminophen 1000 MG per 100 ML InjectionSYa0cece43-256e-4adc-92f8-11a0f473bb835

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-434-006332304340020 BAG in 1 CASE (63323-434-00) / 100 mL in 1 BAG (63323-434-41) 20 bag2020-12-060000-00-00NoNoCurrent
63323-434-4163323043441100 mL in 1 BAG100 mlHistorical