Acetaminophen

Product NDC
55319-185
11-digit product format
553190185
Labeler code
55319
Product ID
55319-185_4654bc95-3028-3506-e063-6294a90acf3f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
FAMILY DOLLAR
Application
ANDA211544
Marketing category
ANDA
Marketing start
2023-09-01
Substance
ACETAMINOPHEN
Active strength
650 mg/1
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
ACETAMINOPHEN650 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui1148399

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-185-10Acetaminophen100 in 1 BOTTLETABLET1005
55319-185-24Acetaminophen24 in 1 BOTTLETABLET245

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-185ACETAMINOPHEN TABLET [FAMILY DOLLAR]4Current NDC, 2 package rows20241212_f824602a-8e7b-b8c3-e053-6294a90a6d9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNf824602a-8e7b-b8c3-e053-6294a90a6d9d5
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDf824602a-8e7b-b8c3-e053-6294a90a6d9d5
11483998 HR APAP 650 MG Extended Release Oral TabletSYf824602a-8e7b-b8c3-e053-6294a90a6d9d5
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYf824602a-8e7b-b8c3-e053-6294a90a6d9d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-185-1055319018510100 TABLET in 1 BOTTLE (55319-185-10) 100 tablet2023-09-01NoNoCurrent
55319-185-245531901852424 TABLET in 1 BOTTLE (55319-185-24) 24 tablet2023-09-01NoNoCurrent