FDA.reportPublic FDA data

Arthritis Pain

Product NDC
53943-200
11-digit product format
539430200
Labeler code
53943
Product ID
53943-200_38cead71-9d6e-ad27-e063-6294a90ab457
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
ANDA211544
Marketing category
ANDA
Marketing start
2020-01-01
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
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
53943-200-02Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE13
53943-200-02Arthritis Pain50 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE503
53943-200-03Arthritis Pain100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1003
53943-200-03Arthritis Pain1 in 1 PACKAGETABLET, EXTENDED RELEASE13
53943-200-09Arthritis Pain225 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE2253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-200ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [DISCOUNT DRUG MART]2Current NDC, Legacy NDC, 5 package rows20200912_973bcf75-8c45-ea16-e053-2a95a90aad63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN973bcf75-8c45-ea16-e053-2a95a90aad633
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD973bcf75-8c45-ea16-e053-2a95a90aad633
11483998 HR APAP 650 MG Extended Release Oral TabletSY973bcf75-8c45-ea16-e053-2a95a90aad633
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY973bcf75-8c45-ea16-e053-2a95a90aad633

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53943-200-02539430200021 BOTTLE, PLASTIC in 1 CARTON (53943-200-02) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2020-01-010000-00-00NoNoCurrent
53943-200-03539430200031 BOTTLE, PLASTIC in 1 PACKAGE (53943-200-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2020-01-030000-00-00NoNoCurrent
53943-200-0953943020009225 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53943-200-09) 2025-06-30NoNoHistorical