FDA.reportPublic FDA data

Acetaminophen

Product NDC
0363-9992
11-digit product format
003639992
Labeler code
0363
Product ID
0363-9992_4652e567-f625-3c68-e063-6394a90a6610
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
WALGREENS
Application
ANDA211544
Marketing category
ANDA
Marketing start
2019-09-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-9992-102020-12-29C16284748780-1ab0e2407-2d60-f274-e053-dbdaa90a64718-Hour Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER - Relieves Minor Muscle Pain for up to 8 hours CONTAINS NO ASPIRIN
0363-9992-202020-12-29C16284748780-1ab0e2407-2d60-f274-e053-dbdaa90a64718-Hour Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER - Relieves Minor Muscle Pain for up to 8 hours CONTAINS NO ASPIRIN
0363-9992-242020-12-29C16284748780-1ab0e2407-2d60-f274-e053-dbdaa90a64718-Hour Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER - Relieves Minor Muscle Pain for up to 8 hours CONTAINS NO ASPIRIN
0363-9992-102020-09-27C16284748780-1ab0e2407-2d60-f274-e053-dbdaa90a64718-Hour Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER - Relieves Minor Muscle Pain for up to 8 hours CONTAINS NO ASPIRIN
0363-9992-202020-09-27C16284748780-1ab0e2407-2d60-f274-e053-dbdaa90a64718-Hour Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER - Relieves Minor Muscle Pain for up to 8 hours CONTAINS NO ASPIRIN
0363-9992-242020-09-27C16284748780-1ab0e2407-2d60-f274-e053-dbdaa90a64718-Hour Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER - Relieves Minor Muscle Pain for up to 8 hours CONTAINS NO ASPIRIN
0363-9992-102020-09-25C16284748780-1ab0e2407-2d60-f274-e053-dbdaa90a64718-Hour Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER - Relieves Minor Muscle Pain for up to 8 hours CONTAINS NO ASPIRIN
0363-9992-202020-09-25C16284748780-1ab0e2407-2d60-f274-e053-dbdaa90a64718-Hour Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER - Relieves Minor Muscle Pain for up to 8 hours CONTAINS NO ASPIRIN
0363-9992-242020-09-25C16284748780-1ab0e2407-2d60-f274-e053-dbdaa90a64718-Hour Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER - Relieves Minor Muscle Pain for up to 8 hours CONTAINS NO ASPIRIN
0363-9992-102020-07-22C16284748780-1ab0e2407-2d60-f274-e053-dbdaa90a64718-Hour Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER - Relieves Minor Muscle Pain for up to 8 hours CONTAINS NO ASPIRIN
0363-9992-202020-07-22C16284748780-1ab0e2407-2d60-f274-e053-dbdaa90a64718-Hour Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER - Relieves Minor Muscle Pain for up to 8 hours CONTAINS NO ASPIRIN
0363-9992-242020-07-22C16284748780-1ab0e2407-2d60-f274-e053-dbdaa90a64718-Hour Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER - Relieves Minor Muscle Pain for up to 8 hours CONTAINS NO ASPIRIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9992-10Acetaminophen100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1008
0363-9992-20Acetaminophen200 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE2008
0363-9992-24Acetaminophen24 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE248

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-9992-10EA - Each0363-9992821fbab3-c4aa-4eb7-a737-e91fb692b5fd12022-06-06
0363-9992-20EA - Each0363-9992d0438d0d-6b93-46c9-b4f5-a1ab556ddc9612022-06-06
0363-9992-24ML - Milliliter0363-9992734defae-5c57-4729-8c48-3d8b71fb692212022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9992ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [WALGREENS]7Current NDC, Legacy NDC, 3 package rows20241218_8f8d43d1-8e73-483e-e053-2a95a90ac99b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN8f8d43d1-8e73-483e-e053-2a95a90ac99b8
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD8f8d43d1-8e73-483e-e053-2a95a90ac99b8
11483998 HR APAP 650 MG Extended Release Oral TabletSY8f8d43d1-8e73-483e-e053-2a95a90ac99b8
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY8f8d43d1-8e73-483e-e053-2a95a90ac99b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-9992-1000363999210100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-9992-10) 2019-09-280000-00-00NoNoCurrent
0363-9992-2000363999220200 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-9992-20) 2019-09-280000-00-00NoNoCurrent
0363-9992-240036399922424 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-9992-24) 2019-09-280000-00-00NoNoCurrent