FDA.reportPublic FDA data

8 Hour Arthritis Pain

Product NDC
63941-300
11-digit product format
639410300
Labeler code
63941
Product ID
63941-300_45b2cc20-7f75-c27a-e063-6294a90a4ea3
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
2020-01-01
Marketing end
2027-12-31
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
8 Hour Arthritis Pain

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
63941-300-028 Hour Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE13
63941-300-028 Hour Arthritis Pain50 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE503
63941-300-048 Hour Arthritis Pain100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-3008 HOUR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]2Current NDC, Legacy NDC, 3 package rows20200916_cd3a7094-ddb5-4583-a1bc-dc6ce280418c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNcd3a7094-ddb5-4583-a1bc-dc6ce280418c3
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDcd3a7094-ddb5-4583-a1bc-dc6ce280418c3
11483998 HR APAP 650 MG Extended Release Oral TabletSYcd3a7094-ddb5-4583-a1bc-dc6ce280418c3
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYcd3a7094-ddb5-4583-a1bc-dc6ce280418c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63941-300-02639410300021 BOTTLE, PLASTIC in 1 CARTON (63941-300-02) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2020-01-012027-11-30NoNoCurrent
63941-300-0463941030004100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63941-300-04) 2020-01-012027-12-31NoNoCurrent