FDA.reportPublic FDA data

Acetaminophen

Product NDC
58602-848
11-digit product format
586020848
Labeler code
58602
Product ID
58602-848_32dce6fb-bdc3-454f-877f-e084d81a0872
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA207229
Marketing category
ANDA
Marketing start
2020-05-16
Substance
ACETAMINOPHEN
Active strength
650 mg/1
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
ACETAMINOPHEN650 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui1148399

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-848-17Acetaminophen1000 in 1 BOTTLETABLET, EXTENDED RELEASE10006
58602-848-21Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE16
58602-848-21Acetaminophen100 in 1 BOTTLETABLET, EXTENDED RELEASE1006
58602-848-35Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE16
58602-848-35Acetaminophen225 in 1 BOTTLETABLET, EXTENDED RELEASE2256
58602-848-40Acetaminophen500 in 1 BOTTLETABLET, EXTENDED RELEASE5006
58602-848-44Acetaminophen400 in 1 BOTTLETABLET, EXTENDED RELEASE4006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNe072e4ab-669d-40ee-b301-0bc15b67792f6
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDe072e4ab-669d-40ee-b301-0bc15b67792f6
11483998 HR APAP 650 MG Extended Release Oral TabletSYe072e4ab-669d-40ee-b301-0bc15b67792f6
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYe072e4ab-669d-40ee-b301-0bc15b67792f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-848-17586020848171000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-848-17) 2026-05-21NoNoHistorical
58602-848-21586020848211 BOTTLE in 1 CARTON (58602-848-21) > 100 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-05-160000-00-00NoNoCurrent
58602-848-35586020848351 BOTTLE in 1 CARTON (58602-848-35) > 225 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-08-130000-00-00NoNoCurrent
58602-848-4058602084840500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-848-40) 2026-05-21NoNoHistorical
58602-848-4458602084844400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-848-44) 2026-05-21NoNoHistorical