Acetaminophen

Product NDC
21130-108
11-digit product format
211300108
Labeler code
21130
Product ID
21130-108_dbcabfb5-6e41-4ffe-a78a-6633188332dc
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Better Living Brands, LLC
Application
ANDA207229
Marketing category
ANDA
Marketing start
2022-06-24
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen
Listing expiration
2027-12-31

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
21130-108-07Acetaminophen24 in 1 BOTTLETABLET, EXTENDED RELEASE245
21130-108-07Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE15
21130-108-35Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE15
21130-108-35Acetaminophen225 in 1 BOTTLETABLET, EXTENDED RELEASE2255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-108ACETAMINOPHEN TABLET, EXTENDED RELEASE [BETTER LIVING BRANDS, LLC]4Current NDC, Legacy NDC, 4 package rows20240126_de3d9840-4ada-5c9a-e053-2a95a90a5721.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNde3d9840-4ada-5c9a-e053-2a95a90a57215
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDde3d9840-4ada-5c9a-e053-2a95a90a57215
11483998 HR APAP 650 MG Extended Release Oral TabletSYde3d9840-4ada-5c9a-e053-2a95a90a57215
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYde3d9840-4ada-5c9a-e053-2a95a90a57215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-108-07211300108071 BOTTLE in 1 CARTON (21130-108-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2022-06-240000-00-00NoNoCurrent
21130-108-35211300108351 BOTTLE in 1 CARTON (21130-108-35) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2022-06-240000-00-00NoNoCurrent