Arthritis Pain

Product NDC
21130-097
11-digit product format
211300097
Labeler code
21130
Product ID
21130-097_fe254d59-11d2-e284-e053-6394a90a340e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
BETTER LIVING BRANDS, LLC
Application
ANDA215486
Marketing category
ANDA
Marketing start
2023-06-13
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
21130-097-01Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE12
21130-097-01Arthritis Pain100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
21130-097-05Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE12
21130-097-05Arthritis Pain50 in 1 BOTTLETABLET, EXTENDED RELEASE502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-097ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [BETTER LIVING BRANDS, LLC]2Current NDC, 4 package rows20230617_ee84323a-b615-3ec6-e053-2995a90a5a26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNee84323a-b615-3ec6-e053-2995a90a5a262
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDee84323a-b615-3ec6-e053-2995a90a5a262
11483998 HR APAP 650 MG Extended Release Oral TabletSYee84323a-b615-3ec6-e053-2995a90a5a262
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYee84323a-b615-3ec6-e053-2995a90a5a262

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-097-01211300097011 BOTTLE in 1 CARTON (21130-097-01) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2023-06-13NoNoCurrent
21130-097-05211300097051 BOTTLE in 1 CARTON (21130-097-05) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2023-06-13NoNoCurrent