FDA.reportPublic FDA data

Acetaminophen Extended-Release Tablets, 650 mg

Product NDC
25000-071
11-digit product format
250000071
Labeler code
25000
Product ID
25000-071_9e2c09cd-1bd4-4a86-8911-ba904d8a76cb
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA215486
Marketing category
ANDA
Marketing start
2021-09-02
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 Extended-Release Tablets, 650 mg
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
25000-071-02Acetaminophen Extended-Release Tablets, 650 mg1 in 1 CARTONTABLET, EXTENDED RELEASE15
25000-071-02Acetaminophen Extended-Release Tablets, 650 mg24 in 1 BOTTLETABLET, EXTENDED RELEASE245
25000-071-08Acetaminophen Extended-Release Tablets, 650 mg1 in 1 CARTONTABLET, EXTENDED RELEASE15
25000-071-08Acetaminophen Extended-Release Tablets, 650 mg100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
25000-071-10Acetaminophen Extended-Release Tablets, 650 mg1 in 1 CARTONTABLET, EXTENDED RELEASE15
25000-071-10Acetaminophen Extended-Release Tablets, 650 mg225 in 1 BOTTLETABLET, EXTENDED RELEASE2255
25000-071-11Acetaminophen Extended-Release Tablets, 650 mg290 in 1 BOTTLETABLET, EXTENDED RELEASE2905
25000-071-11Acetaminophen Extended-Release Tablets, 650 mg1 in 1 CARTONTABLET, EXTENDED RELEASE15
25000-071-45Acetaminophen Extended-Release Tablets, 650 mg400 in 1 BOTTLETABLET, EXTENDED RELEASE4005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-071ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 MG (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MARKSANS PHARMA LIMITED]5Current NDC, Legacy NDC, 9 package rows20231019_d973a910-5fe0-4a85-884d-2c3987836691.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNd973a910-5fe0-4a85-884d-2c39878366915
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDd973a910-5fe0-4a85-884d-2c39878366915
11483998 HR APAP 650 MG Extended Release Oral TabletSYd973a910-5fe0-4a85-884d-2c39878366915
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYd973a910-5fe0-4a85-884d-2c39878366915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25000-071-02250000071021 BOTTLE in 1 CARTON (25000-071-02) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-09-020000-00-00NoNoCurrent
25000-071-08250000071081 BOTTLE in 1 CARTON (25000-071-08) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-09-020000-00-00NoNoCurrent
25000-071-10250000071101 BOTTLE in 1 CARTON (25000-071-10) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-09-020000-00-00NoNoCurrent
25000-071-11250000071111 BOTTLE in 1 CARTON (25000-071-11) / 290 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-09-020000-00-00NoNoCurrent
25000-071-4525000007145400 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-071-45) 2021-09-070000-00-00NoNoCurrent