FDA.reportPublic FDA data

8 Hour Arthritis Pain

Product NDC
83324-083
11-digit product format
833240083
Labeler code
83324
Product ID
83324-083_1ac70227-c7d7-de60-e063-6394a90aeed7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.
Application
ANDA211544
Marketing category
ANDA
Marketing start
2024-05-01
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
83324-083-018 Hour Arthritis Pain100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1002
83324-083-508 Hour Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE12
83324-083-508 Hour Arthritis Pain50 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-083-50EA - Each83324-083df41ad4a-b1e6-4114-8f66-8f8e28ee925412025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-0838 HOUR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Current NDC, 3 package rows20240615_b098ebf6-a76d-4550-b5c4-fdc3b4ceb9a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNb098ebf6-a76d-4550-b5c4-fdc3b4ceb9a82
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDb098ebf6-a76d-4550-b5c4-fdc3b4ceb9a82
11483998 HR APAP 650 MG Extended Release Oral TabletSYb098ebf6-a76d-4550-b5c4-fdc3b4ceb9a82
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYb098ebf6-a76d-4550-b5c4-fdc3b4ceb9a82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-083-0183324008301100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83324-083-01) 2024-05-01NoNoHistorical
83324-083-50833240083501 BOTTLE, PLASTIC in 1 CARTON (83324-083-50) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2024-05-01NoNoHistorical