Acetaminophen

Product NDC
68196-935
11-digit product format
681960935
Labeler code
68196
Product ID
68196-935_4653bc49-45c1-1753-e063-6394a90aa02f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
SAM'S WEST INC
Application
ANDA211544
Marketing category
ANDA
Marketing start
2022-12-28
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
Rxcui198444

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-935-20Acetaminophen200 in 1 BOTTLETABLET2008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-935ACETAMINOPHEN TABLET [SAM'S WEST INC]6Current NDC, Legacy NDC, 1 package rows20241120_e77c2bc7-0258-4a6d-e053-2a95a90afe6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198444acetaminophen 650 MG Oral TabletPSNe77c2bc7-0258-4a6d-e053-2a95a90afe6e8
198444acetaminophen 650 MG Oral TabletSCDe77c2bc7-0258-4a6d-e053-2a95a90afe6e8
198444APAP 650 MG Oral TabletSYe77c2bc7-0258-4a6d-e053-2a95a90afe6e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-935-2068196093520200 TABLET in 1 BOTTLE (68196-935-20) 200 tablet2022-12-280000-00-00NoNoCurrent