FDA.reportPublic FDA data

8 Hour Arthritis Pain

Product NDC
46122-629
11-digit product format
461220629
Labeler code
46122
Product ID
46122-629_090568cf-d90d-2f8a-e063-6394a90a0136
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 Arthritis Pain
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
46122-629-628 Hour Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE16
46122-629-628 Hour Arthritis Pain24 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE246
46122-629-718 Hour Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE16
46122-629-718 Hour Arthritis Pain50 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE506
46122-629-788 Hour Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE16
46122-629-788 Hour Arthritis Pain100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1006
46122-629-818 Hour Arthritis Pain200 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE2006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-629-62EA - Each46122-6293cf43711-818b-447e-a1a4-fd0eb9ff8a5612023-12-05
46122-629-71EA - Each46122-629732df20e-a28c-403c-8fc8-c7306c6b5f8712023-02-06
46122-629-78EA - Each46122-629c91738ad-032a-4728-9fc3-c678f3960ab112020-04-20
46122-629-81EA - Each46122-629a984f8e0-563c-4db1-a60e-44d0a719db3c12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-6298 HOUR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [AMERISOURCE BERGEN]6Current NDC, Legacy NDC, 7 package rows20231101_7888eff3-3030-4aa0-89e3-9795aa214659.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN7888eff3-3030-4aa0-89e3-9795aa2146596
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD7888eff3-3030-4aa0-89e3-9795aa2146596
11483998 HR APAP 650 MG Extended Release Oral TabletSY7888eff3-3030-4aa0-89e3-9795aa2146596
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY7888eff3-3030-4aa0-89e3-9795aa2146596

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-629-62461220629621 BOTTLE, PLASTIC in 1 CARTON (46122-629-62) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2023-01-30NoNoHistorical
46122-629-71461220629711 BOTTLE, PLASTIC in 1 CARTON (46122-629-71) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2020-01-130000-00-00NoNoCurrent
46122-629-78461220629781 BOTTLE, PLASTIC in 1 CARTON (46122-629-78) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2020-01-130000-00-00NoNoCurrent
46122-629-8146122062981200 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (46122-629-81) 2020-01-130000-00-00NoNoCurrent