Acetaminophen

Product NDC
69842-635
11-digit product format
698420635
Labeler code
69842
Product ID
69842-635_8394aaec-e897-48bb-bda2-cc2b64a6cd64
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
ANDA207229
Marketing category
ANDA
Marketing start
2022-10-13
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
Acetaminophen
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
69842-635-07Acetaminophen24 in 1 BOTTLETABLET, EXTENDED RELEASE245
69842-635-07Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-635ACETAMINOPHEN TABLET, EXTENDED RELEASE [CVS PHARMACY, INC.]5Current NDC, Legacy NDC, 2 package rows20240126_e577fdf0-85b1-1471-e053-2995a90a6fcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNe577fdf0-85b1-1471-e053-2995a90a6fcd5
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDe577fdf0-85b1-1471-e053-2995a90a6fcd5
11483998 HR APAP 650 MG Extended Release Oral TabletSYe577fdf0-85b1-1471-e053-2995a90a6fcd5
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYe577fdf0-85b1-1471-e053-2995a90a6fcd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-635-07698420635071 BOTTLE in 1 CARTON (69842-635-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2022-10-130000-00-00NoNoCurrent