major acetaminophen

Product NDC
0904-6883
11-digit product format
009046883
Labeler code
0904
Product ID
0904-6883_69ef9f35-add0-44cf-944d-fc69d1a7dd02
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075077
Marketing category
ANDA
Marketing start
2019-03-04
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
major 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
0904-6883-65major acetaminophen400 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE4003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6883MAJOR ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 1 package rows20221111_ca9e1dae-eefb-4653-952f-2fde09059693.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNca9e1dae-eefb-4653-952f-2fde090596933
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDca9e1dae-eefb-4653-952f-2fde090596933
11483998 HR APAP 650 MG Extended Release Oral TabletSYca9e1dae-eefb-4653-952f-2fde090596933
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYca9e1dae-eefb-4653-952f-2fde090596933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-6883-6500904688365400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0904-6883-65) 2019-03-040000-00-00NoNoCurrent