FDA.reportPublic FDA data

Acetaminophen

Product NDC
79481-0183
11-digit product format
794810183
Labeler code
79481
Product ID
79481-0183_46512232-be54-7eef-e063-6294a90a925e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
MEIJER DISTRIBUTION INC
Application
ANDA211544
Marketing category
ANDA
Marketing start
2023-07-17
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
79481-0183-1Acetaminophen100 in 1 BOTTLETABLET1007
79481-0183-2Acetaminophen225 in 1 BOTTLETABLET2257
79481-0183-4Acetaminophen400 in 1 BOTTLETABLET4007
79481-0183-5Acetaminophen150 in 1 BOTTLETABLET1507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0183ACETAMINOPHEN TABLET [MEIJER DISTRIBUTION INC]5Current NDC, 4 package rows20241212_ed23c587-7806-1f64-e053-2a95a90aea7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNed23c587-7806-1f64-e053-2a95a90aea7f7
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDed23c587-7806-1f64-e053-2a95a90aea7f7
11483998 HR APAP 650 MG Extended Release Oral TabletSYed23c587-7806-1f64-e053-2a95a90aea7f7
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYed23c587-7806-1f64-e053-2a95a90aea7f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0183-179481018301100 TABLET in 1 BOTTLE (79481-0183-1) 100 tablet2023-07-17NoNoCurrent
79481-0183-279481018302225 TABLET in 1 BOTTLE (79481-0183-2) 225 tablet2023-07-17NoNoCurrent
79481-0183-479481018304400 TABLET in 1 BOTTLE (79481-0183-4) 400 tablet2023-07-17NoNoCurrent
79481-0183-579481018305150 TABLET in 1 BOTTLE (79481-0183-5) 150 tablet2023-07-17NoNoCurrent