FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
71335-1340
11-digit product format
713351340
Labeler code
71335
Product ID
71335-1340_4534cfd2-5503-42bd-829b-5db07a93ce4b
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211544
Marketing category
ANDA
Marketing start
2019-07-01
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
71335-1340-1ACETAMINOPHEN30 in 1 BOTTLETABLET, EXTENDED RELEASE306
71335-1340-2ACETAMINOPHEN100 in 1 BOTTLETABLET, EXTENDED RELEASE1006
71335-1340-3ACETAMINOPHEN50 in 1 BOTTLETABLET, EXTENDED RELEASE506
71335-1340-4ACETAMINOPHEN60 in 1 BOTTLETABLET, EXTENDED RELEASE606
71335-1340-5ACETAMINOPHEN120 in 1 BOTTLETABLET, EXTENDED RELEASE1206
71335-1340-6ACETAMINOPHEN19 in 1 BOTTLETABLET, EXTENDED RELEASE196
71335-1340-7ACETAMINOPHEN20 in 1 BOTTLETABLET, EXTENDED RELEASE206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1340ACETAMINOPHEN TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 7 package rows20241025_f6dc5576-9ba3-436c-87f5-8d0d6258adef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNf6dc5576-9ba3-436c-87f5-8d0d6258adef6
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDf6dc5576-9ba3-436c-87f5-8d0d6258adef6
11483998 HR APAP 650 MG Extended Release Oral TabletSYf6dc5576-9ba3-436c-87f5-8d0d6258adef6
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYf6dc5576-9ba3-436c-87f5-8d0d6258adef6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1340-17133513400130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-1) 2019-12-040000-00-00NoNoCurrent
71335-1340-271335134002100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-2) 2019-08-200000-00-00NoNoCurrent
71335-1340-37133513400350 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-3) 2024-10-070000-00-00NoNoCurrent
71335-1340-47133513400460 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-4) 2024-10-070000-00-00NoNoCurrent
71335-1340-571335134005120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-5) 2024-07-230000-00-00NoNoCurrent
71335-1340-67133513400619 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-6) 2024-10-07NoNoHistorical
71335-1340-77133513400720 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-7) 2024-10-07NoNoHistorical