topcare 8 hr arthritis pain relief

Product NDC
36800-455
11-digit product format
368000455
Labeler code
36800
Product ID
36800-455_6be40153-a08e-4a37-8416-75167ab0efa6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA075077
Marketing category
ANDA
Marketing start
2018-07-10
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
topcare 8 hr 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
36800-455-62topcare 8 hr arthritis pain relief1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE16
36800-455-62topcare 8 hr arthritis pain relief24 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE246
36800-455-71topcare 8 hr arthritis pain relief1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE16
36800-455-71topcare 8 hr arthritis pain relief50 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE506
36800-455-78topcare 8 hr arthritis pain relief1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE16
36800-455-78topcare 8 hr arthritis pain relief100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1006
36800-455-79topcare 8 hr arthritis pain relief400 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE4006
36800-455-83topcare 8 hr arthritis pain relief1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE16
36800-455-83topcare 8 hr arthritis pain relief225 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE2256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-455TOPCARE 8 HR ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 9 package rows20240823_a82f8818-1c22-46d0-b05f-698d2395ac48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNa82f8818-1c22-46d0-b05f-698d2395ac486
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDa82f8818-1c22-46d0-b05f-698d2395ac486
11483998 HR APAP 650 MG Extended Release Oral TabletSYa82f8818-1c22-46d0-b05f-698d2395ac486
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYa82f8818-1c22-46d0-b05f-698d2395ac486

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-455-62368000455621 BOTTLE in 1 CARTON (36800-455-62) > 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-07-100000-00-00NoNoCurrent
36800-455-71368000455711 BOTTLE in 1 CARTON (36800-455-71) > 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-07-100000-00-00NoNoCurrent
36800-455-78368000455781 BOTTLE in 1 CARTON (36800-455-78) > 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-07-100000-00-00NoNoCurrent
36800-455-79368000455791 BOTTLE in 1 CARTON (36800-455-79) > 400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-10-160000-00-00NoNoCurrent
36800-455-83368000455831 BOTTLE in 1 CARTON (36800-455-83) / 225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2024-04-16NoNoCurrent