Acetaminophen

Product NDC
24201-110
11-digit product format
242010110
Labeler code
24201
Product ID
24201-110_dfa24eae-037c-41c4-b423-96a3c1436fa4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA202605
Marketing category
ANDA
Marketing start
2023-03-01
Substance
ACETAMINOPHEN
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen
Listing expiration
2027-12-31

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
24201-110-24Acetaminophen24 in 1 CARTONINJECTION, SOLUTION245
24201-110-24Acetaminophen100 mL in 1 VIAL, GLASSINJECTION, SOLUTION1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24201-110-24ML - Milliliter24201-11089d3b19f-6b76-41ef-99cd-f5f8a6cafdbd12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24201-110ACETAMINOPHEN INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, 2 package rows20230301_7243bf2c-2c44-4dff-8a9e-d788d31dca86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483017acetaminophen 1000 MG in 100 ML InjectionPSN7243bf2c-2c44-4dff-8a9e-d788d31dca865
483017100 ML acetaminophen 10 MG/ML InjectionSCD7243bf2c-2c44-4dff-8a9e-d788d31dca865
483017100 ML APAP 10 MG/ML InjectionSY7243bf2c-2c44-4dff-8a9e-d788d31dca865
483017acetaminophen 1000 MG per 100 ML InjectionSY7243bf2c-2c44-4dff-8a9e-d788d31dca865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24201-110-242420101102424 VIAL, GLASS in 1 CARTON (24201-110-24) / 100 mL in 1 VIAL, GLASS2023-03-01NoNoHistorical