Acetaminophen

Product NDC
0143-9386
11-digit product format
001439386
Labeler code
0143
Product ID
0143-9386_e5ea1bad-d98b-475c-be6b-1d6415e3edff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA206968
Marketing category
NDA
Marketing start
2022-06-03
Substance
ACETAMINOPHEN
Active strength
1000 mg/100mL
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
ACETAMINOPHEN1000 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui483017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9386-01Acetaminophen100 mL in 1 BAGINJECTION1006
0143-9386-10Acetaminophen10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9386-01ML - Milliliter0143-938616e26c2b-d69d-46d8-88e4-bc00025437d912022-11-07
0143-9386-10ML - Milliliter0143-9386def92a87-b025-4e7f-a34d-23a0ed9af72312022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9386ACETAMINOPHEN INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20240608_88c29438-3648-4b09-bd43-70ad7a35bcb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483017acetaminophen 1000 MG in 100 ML InjectionPSN88c29438-3648-4b09-bd43-70ad7a35bcb56
483017100 ML acetaminophen 10 MG/ML InjectionSCD88c29438-3648-4b09-bd43-70ad7a35bcb56
483017100 ML APAP 10 MG/ML InjectionSY88c29438-3648-4b09-bd43-70ad7a35bcb56
483017acetaminophen 1000 MG per 100 ML InjectionSY88c29438-3648-4b09-bd43-70ad7a35bcb56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9386-0100143938601100 mL in 1 BAG100 mlHistorical
0143-9386-100014393861010 BAG in 1 CARTON (0143-9386-10) / 100 mL in 1 BAG (0143-9386-01) 10 bag2022-06-030000-00-00NoNoCurrent