Acetaminophen

Product NDC
55579-405
11-digit product format
555790405
Labeler code
55579
Product ID
55579-405_d92bd5a7-d41c-31d1-e053-2995a90a143a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Solupharm Pharmazeutische Erzeugnisse GmbH
Application
ANDA202605
Marketing category
ANDA
Marketing start
2020-12-07
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
55579-405-24Acetaminophen100 mL in 1 VIAL, GLASSINJECTION, SOLUTION1001
55579-405-24Acetaminophen24 in 1 CARTONINJECTION, SOLUTION241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55579-405ACETAMINOPHEN INJECTION, SOLUTION [SOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH]1Current NDC, Legacy NDC, 2 package rows20220302_d92be8ae-3173-0a9d-e053-2995a90abc63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483017acetaminophen 1000 MG in 100 ML InjectionPSNd92be8ae-3173-0a9d-e053-2995a90abc631
483017100 ML acetaminophen 10 MG/ML InjectionSCDd92be8ae-3173-0a9d-e053-2995a90abc631
483017100 ML APAP 10 MG/ML InjectionSYd92be8ae-3173-0a9d-e053-2995a90abc631
483017acetaminophen 1000 MG per 100 ML InjectionSYd92be8ae-3173-0a9d-e053-2995a90abc631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55579-405-245557904052424 VIAL, GLASS in 1 CARTON (55579-405-24) / 100 mL in 1 VIAL, GLASS2020-12-070000-00-00NoNoCurrent