FDA.reportPublic FDA data

8 Hour Pain Relief

Product NDC
46122-630
11-digit product format
461220630
Labeler code
46122
Product ID
46122-630_1e004cc6-5802-1e62-e063-6294a90aa220
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AMERISOURCE BERGEN
Application
ANDA211544
Marketing category
ANDA
Marketing start
2020-01-13
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
8 Hour Pain Relief
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
46122-630-718 Hour Pain Relief50 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE508
46122-630-718 Hour Pain Relief1 in 1 PACKAGETABLET, EXTENDED RELEASE18
46122-630-788 Hour Pain Relief1 in 1 CARTONTABLET, EXTENDED RELEASE18
46122-630-788 Hour Pain Relief100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-630-71EA - Each46122-63040a8365b-dfa1-422b-a8cd-c839baee584612025-03-04
46122-630-78EA - Each46122-63082d8b974-4807-46fd-aaba-ab48c52e85a212021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-6308 HOUR PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [AMERISOURCE BERGEN]8Current NDC, Legacy NDC, 4 package rows20240725_9ab903aa-7170-460b-9527-e3df223f5f55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN9ab903aa-7170-460b-9527-e3df223f5f558
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD9ab903aa-7170-460b-9527-e3df223f5f558
11483998 HR APAP 650 MG Extended Release Oral TabletSY9ab903aa-7170-460b-9527-e3df223f5f558
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY9ab903aa-7170-460b-9527-e3df223f5f558

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-630-71461220630711 BOTTLE, PLASTIC in 1 PACKAGE (46122-630-71) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2024-08-270000-00-00NoNoCurrent
46122-630-78461220630781 BOTTLE, PLASTIC in 1 CARTON (46122-630-78) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2020-01-130000-00-00NoNoCurrent