FDA.reportPublic FDA data

Arthritis Pain Relief

Product NDC
36800-632
11-digit product format
368000632
Labeler code
36800
Product ID
36800-632_ea392a2b-465a-6a66-e053-2a95a90a62c8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
ANDA211544
Marketing category
ANDA
Marketing start
2022-10-04
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
Arthritis 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
36800-632-01Arthritis Pain Relief24 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE242
36800-632-01Arthritis Pain Relief1 in 1 CARTONTABLET, EXTENDED RELEASE12
36800-632-02Arthritis Pain Relief50 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE502
36800-632-02Arthritis Pain Relief1 in 1 CARTONTABLET, EXTENDED RELEASE12
36800-632-03Arthritis Pain Relief1 in 1 CARTONTABLET, EXTENDED RELEASE12
36800-632-03Arthritis Pain Relief100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1002
36800-632-05Arthritis Pain Relief150 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-632ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 7 package rows20221005_e60aa992-f5f7-3506-e053-2995a90a7abd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNe60aa992-f5f7-3506-e053-2995a90a7abd2
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDe60aa992-f5f7-3506-e053-2995a90a7abd2
11483998 HR APAP 650 MG Extended Release Oral TabletSYe60aa992-f5f7-3506-e053-2995a90a7abd2
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYe60aa992-f5f7-3506-e053-2995a90a7abd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-632-01368000632011 BOTTLE, PLASTIC in 1 CARTON (36800-632-01) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2022-10-040000-00-00NoNoCurrent
36800-632-02368000632021 BOTTLE, PLASTIC in 1 CARTON (36800-632-02) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2022-10-040000-00-00NoNoCurrent
36800-632-03368000632031 BOTTLE, PLASTIC in 1 CARTON (36800-632-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2022-10-040000-00-00NoNoCurrent
36800-632-0536800063205150 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (36800-632-05) 2022-10-040000-00-00NoNoCurrent