FDA.reportPublic FDA data

Acetaminophen

Product NDC
69842-322
11-digit product format
698420322
Labeler code
69842
Product ID
69842-322_46a0f3f6-a3db-49b3-e063-6294a90ad1c7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
CVS PHARMACY INC
Application
ANDA211544
Marketing category
ANDA
Marketing start
2021-02-01
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
Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui1148399

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-322-102023-03-02C16284748780-1f386c649-b18c-0266-e053-dadaa90a7c1aArthritis Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER ARTHRITIS 8 HOUR CAPLETS - For the temporary relief of minor arthritis pain - Lasts up to 8 hours
69842-322-242023-03-02C16284748780-1f386c649-b18c-0266-e053-dadaa90a7c1aArthritis Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER ARTHRITIS 8 HOUR CAPLETS - For the temporary relief of minor arthritis pain - Lasts up to 8 hours
69842-322-102023-01-30C16284748780-1f386c649-b18c-0266-e053-dadaa90a7c1aArthritis Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER ARTHRITIS 8 HOUR CAPLETS - For the temporary relief of minor arthritis pain - Lasts up to 8 hours
69842-322-242023-01-30C16284748780-1f386c649-b18c-0266-e053-dadaa90a7c1aArthritis Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER ARTHRITIS 8 HOUR CAPLETS - For the temporary relief of minor arthritis pain - Lasts up to 8 hours

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-322-10Acetaminophen100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1007
69842-322-24Acetaminophen24 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE247

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-322ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY INC]5Current NDC, Legacy NDC, 2 package rows20241120_bd8ce39f-ccf8-3976-e053-2a95a90abb1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNbd8ce39f-ccf8-3976-e053-2a95a90abb1f7
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDbd8ce39f-ccf8-3976-e053-2a95a90abb1f7
11483998 HR APAP 650 MG Extended Release Oral TabletSYbd8ce39f-ccf8-3976-e053-2a95a90abb1f7
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYbd8ce39f-ccf8-3976-e053-2a95a90abb1f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-322-1069842032210100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69842-322-10) 2021-02-010000-00-00NoNoCurrent
69842-322-246984203222424 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69842-322-24) 2021-02-010000-00-00NoNoCurrent