FDA.reportPublic FDA data

Acetaminophen

Product NDC
63868-413
11-digit product format
638680413
Labeler code
63868
Product ID
63868-413_b7b5195b-a2aa-b60d-e053-2995a90abd17
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
ANDA211544
Marketing category
ANDA
Marketing start
2019-12-31
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-413-502023-01-30C16284748780-1ab0e2407-27fe-f274-e053-dbdaa90a64718 HOUR Muscle Aches & Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For up to 8 hours relief of Minor Muscle Aches & Pain
63868-413-502020-12-30C16284748780-1ab0e2407-27fe-f274-e053-dbdaa90a64718 HOUR Muscle Aches & Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For up to 8 hours relief of Minor Muscle Aches & Pain
63868-413-502020-09-27C16284748780-1ab0e2407-27fe-f274-e053-dbdaa90a64718 HOUR Muscle Aches & Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For up to 8 hours relief of Minor Muscle Aches & Pain
63868-413-502020-09-25C16284748780-1ab0e2407-27fe-f274-e053-dbdaa90a64718 HOUR Muscle Aches & Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For up to 8 hours relief of Minor Muscle Aches & Pain
63868-413-502020-07-22C16284748780-1ab0e2407-27fe-f274-e053-dbdaa90a64718 HOUR Muscle Aches & Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For up to 8 hours relief of Minor Muscle Aches & Pain

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-413-50Acetaminophen50 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-413ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]2Legacy NDC, 1 package rows20201231_9f1c14af-8cfd-0a5d-e053-2a95a90ac940.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN9f1c14af-8cfd-0a5d-e053-2a95a90ac9402
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD9f1c14af-8cfd-0a5d-e053-2a95a90ac9402
11483998 HR APAP 650 MG Extended Release Oral TabletSY9f1c14af-8cfd-0a5d-e053-2a95a90ac9402
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY9f1c14af-8cfd-0a5d-e053-2a95a90ac9402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-413-506386804135050 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63868-413-50) 2019-12-310000-00-00NoNoCurrent