FDA.reportPublic FDA data

Acetaminophen

Product NDC
58602-873
11-digit product format
586020873
Labeler code
58602
Product ID
58602-873_144490f4-f2a5-4c6d-abf2-5e7ee65d66d7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA207229
Marketing category
ANDA
Marketing start
2021-12-27
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
58602-873-07Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE14
58602-873-07Acetaminophen24 in 1 BOTTLETABLET, EXTENDED RELEASE244
58602-873-14Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE14
58602-873-14Acetaminophen50 in 1 BOTTLETABLET, EXTENDED RELEASE504
58602-873-21Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE14
58602-873-21Acetaminophen100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
58602-873-29Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE14
58602-873-29Acetaminophen150 in 1 BOTTLETABLET, EXTENDED RELEASE1504
58602-873-34Acetaminophen200 in 1 BOTTLETABLET, EXTENDED RELEASE2004
58602-873-35Acetaminophen225 in 1 BOTTLETABLET, EXTENDED RELEASE2254
58602-873-36Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE14
58602-873-36Acetaminophen250 in 1 BOTTLETABLET, EXTENDED RELEASE2504
58602-873-40Acetaminophen500 in 1 BOTTLETABLET, EXTENDED RELEASE5004
58602-873-41Acetaminophen1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004
58602-873-44Acetaminophen400 in 1 BOTTLETABLET, EXTENDED RELEASE4004
58602-873-67Acetaminophen290 in 1 BOTTLETABLET, EXTENDED RELEASE2904
58602-873-76Acetaminophen325 in 1 BOTTLETABLET, EXTENDED RELEASE3254
58602-873-94Acetaminophen100 in 1 BOTTLETABLET, EXTENDED RELEASE1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-873ACETAMINOPHEN TABLET, EXTENDED RELEASE [AUROHEALTH LLC]4Current NDC, Legacy NDC, 18 package rows20240126_f076fd33-9eaf-49b9-b0ee-6a349567c5ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNf076fd33-9eaf-49b9-b0ee-6a349567c5ff4
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDf076fd33-9eaf-49b9-b0ee-6a349567c5ff4
11483998 HR APAP 650 MG Extended Release Oral TabletSYf076fd33-9eaf-49b9-b0ee-6a349567c5ff4
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYf076fd33-9eaf-49b9-b0ee-6a349567c5ff4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-873-07586020873071 BOTTLE in 1 CARTON (58602-873-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-12-270000-00-00NoNoCurrent
58602-873-14586020873141 BOTTLE in 1 CARTON (58602-873-14) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-12-270000-00-00NoNoCurrent
58602-873-21586020873211 BOTTLE in 1 CARTON (58602-873-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-12-270000-00-00NoNoCurrent
58602-873-29586020873291 BOTTLE in 1 CARTON (58602-873-29) / 150 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-12-270000-00-00NoNoCurrent
58602-873-3458602087334200 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-34) 2021-12-270000-00-00NoNoCurrent
58602-873-3558602087335225 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-35) 2021-12-270000-00-00NoNoCurrent
58602-873-36586020873361 BOTTLE in 1 CARTON (58602-873-36) / 250 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-12-270000-00-00NoNoCurrent
58602-873-4058602087340500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-40) 2021-12-270000-00-00NoNoCurrent
58602-873-41586020873411000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-41) 2021-12-270000-00-00NoNoCurrent
58602-873-4458602087344400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-44) 2021-12-270000-00-00NoNoCurrent
58602-873-6758602087367290 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-67) 2021-12-270000-00-00NoNoCurrent
58602-873-7658602087376325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-76) 2021-12-270000-00-00NoNoCurrent
58602-873-9458602087394100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-94) 2021-12-270000-00-00NoNoCurrent