FDA.reportPublic FDA data

Acetaminophen

Product NDC
69842-037
11-digit product format
698420037
Labeler code
69842
Product ID
69842-037_3ac76330-16d2-44f6-b013-8683059b83a9
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
2020-12-23
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
69842-037-35Acetaminophen225 in 1 BOTTLETABLET, EXTENDED RELEASE2258
69842-037-44Acetaminophen400 in 1 BOTTLETABLET, EXTENDED RELEASE4008
69842-037-91Acetaminophen150 in 1 BOTTLETABLET, EXTENDED RELEASE1508
69842-037-91Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-037-35EA - Each69842-03734b9136e-6188-40fa-a005-bf8d45d14b2e12023-01-09
69842-037-44EA - Each69842-0372f0ab66e-ea07-4f74-b8c0-703e30a1b5ca12023-01-09
69842-037-91EA - Each69842-037af7034d9-fb99-4d6a-a71e-6816aa7067a512023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-037ACETAMINOPHEN TABLET, EXTENDED RELEASE [CVS PHARMACY, INC.]8Current NDC, Legacy NDC, 4 package rows20240126_b70beee4-407e-547c-e053-2a95a90af22a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNb70beee4-407e-547c-e053-2a95a90af22a8
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDb70beee4-407e-547c-e053-2a95a90af22a8
11483998 HR APAP 650 MG Extended Release Oral TabletSYb70beee4-407e-547c-e053-2a95a90af22a8
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYb70beee4-407e-547c-e053-2a95a90af22a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-037-3569842003735225 TABLET, EXTENDED RELEASE in 1 BOTTLE (69842-037-35) 2020-12-230000-00-00NoNoCurrent
69842-037-4469842003744400 TABLET, EXTENDED RELEASE in 1 BOTTLE (69842-037-44) 2020-12-230000-00-00NoNoCurrent
69842-037-91698420037911 BOTTLE in 1 CARTON (69842-037-91) > 150 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-12-230000-00-00NoNoCurrent