Acetaminophen

Product NDC
44567-340
11-digit product format
445670340
Labeler code
44567
Product ID
44567-340_ffa85b8b-2890-4f03-aaaa-816a181f048c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA215403
Marketing category
ANDA
Marketing start
2023-05-03
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
44567-340-01Acetaminophen100 mL in 1 BAGINJECTION, SOLUTION1004
44567-340-10Acetaminophen10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-340ACETAMINOPHEN INJECTION, SOLUTION [WG CRITICAL CARE, LLC]4Current NDC, 2 package rows20240625_60f0d5b2-cab4-4a7c-8b53-1526a0908a54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483017acetaminophen 1000 MG in 100 ML InjectionPSN60f0d5b2-cab4-4a7c-8b53-1526a0908a544
483017100 ML acetaminophen 10 MG/ML InjectionSCD60f0d5b2-cab4-4a7c-8b53-1526a0908a544
483017100 ML APAP 10 MG/ML InjectionSY60f0d5b2-cab4-4a7c-8b53-1526a0908a544
483017acetaminophen 1000 MG per 100 ML InjectionSY60f0d5b2-cab4-4a7c-8b53-1526a0908a544

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44567-340-0144567034001100 mL in 1 BAG100 mlHistorical
44567-340-104456703401010 BAG in 1 CARTON (44567-340-10) / 100 mL in 1 BAG (44567-340-01) 10 bag2023-05-03NoNoCurrent