8 Hour Pain Relief

Product NDC
63941-401
11-digit product format
639410401
Labeler code
63941
Product ID
63941-401_45b2da7e-84d5-5b1d-e063-6394a90a0cf8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
VALU MERCHANDISERS COMPANY
Application
ANDA211544
Marketing category
ANDA
Marketing start
2019-12-12
Marketing end
2027-11-30
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Current FDA listing
Yes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-401-028 Hour Pain Relief50 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE505
63941-401-028 Hour Pain Relief1 in 1 CARTONTABLET, EXTENDED RELEASE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-4018 HOUR PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]4Current NDC, Legacy NDC, 2 package rows20240615_d11a7412-a543-0e34-e053-2995a90afd63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNd11a7412-a543-0e34-e053-2995a90afd635
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDd11a7412-a543-0e34-e053-2995a90afd635
11483998 HR APAP 650 MG Extended Release Oral TabletSYd11a7412-a543-0e34-e053-2995a90afd635
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYd11a7412-a543-0e34-e053-2995a90afd635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63941-401-02639410401021 BOTTLE, PLASTIC in 1 CARTON (63941-401-02) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2019-12-122027-11-30NoNoCurrent