FDA.reportPublic FDA data

Acetaminophen

Product NDC
68788-8559
11-digit product format
687888559
Labeler code
68788
Product ID
68788-8559_b0b0d57d-1c24-4852-8c08-6757a894023f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-08
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8559-1Acetaminophen100 in 1 BOTTLETABLET1003
68788-8559-2Acetaminophen20 in 1 BOTTLETABLET203
68788-8559-3Acetaminophen30 in 1 BOTTLETABLET303
68788-8559-5Acetaminophen50 in 1 BOTTLETABLET503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8559-1EA - Each68788-8559b07c23e1-d2cc-4170-807a-c2af802d3c5b12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8559ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20250508_b6abfbbb-9826-4cd6-940f-3a314480a5a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNb6abfbbb-9826-4cd6-940f-3a314480a5a53
198440acetaminophen 500 MG Oral TabletSCDb6abfbbb-9826-4cd6-940f-3a314480a5a53
198440APAP 500 MG Oral TabletSYb6abfbbb-9826-4cd6-940f-3a314480a5a53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8559-168788855901100 TABLET in 1 BOTTLE (68788-8559-1) 100 tablet2024-01-08NoNoHistorical
68788-8559-26878885590220 TABLET in 1 BOTTLE (68788-8559-2) 20 tablet2025-05-06NoNoHistorical
68788-8559-36878885590330 TABLET in 1 BOTTLE (68788-8559-3) 30 tablet2025-05-06NoNoHistorical
68788-8559-56878885590550 TABLET in 1 BOTTLE (68788-8559-5) 50 tablet2025-05-06NoNoHistorical