Acetaminophen

Product NDC
65145-157
11-digit product format
651450157
Labeler code
65145
Product ID
65145-157_b6f83919-8608-4648-9ac6-e13eadac8404
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA219096
Marketing category
ANDA
Marketing start
2025-12-18
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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65145-157-01Acetaminophen1 in 1 POUCHINJECTION, SOLUTION11
65145-157-01Acetaminophen100 mL in 1 BAGINJECTION, SOLUTION1001
65145-157-10Acetaminophen10 in 1 CASEINJECTION, SOLUTION101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483017acetaminophen 1000 MG in 100 ML InjectionPSNb6f83919-8608-4648-9ac6-e13eadac84041
483017100 ML acetaminophen 10 MG/ML InjectionSCDb6f83919-8608-4648-9ac6-e13eadac84041
483017100 ML APAP 10 MG/ML InjectionSYb6f83919-8608-4648-9ac6-e13eadac84041
483017acetaminophen 1000 MG per 100 ML InjectionSYb6f83919-8608-4648-9ac6-e13eadac84041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-157-01651450157011 in 1 POUCHHistorical
65145-157-106514501571010 POUCH in 1 CASE (65145-157-10) / 1 BAG in 1 POUCH (65145-157-01) / 100 mL in 1 BAG10 pouch2025-12-18NoNoHistorical