acetaminophen

Product NDC
68788-8070
Requested package NDC
68788-8070-5
11-digit product format
687888070
Labeler code
68788
Product ID
68788-8070_5d72e532-051c-488b-8879-e22388243f01
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-08-23
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68788-807068788-8070-5DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8070-1EA - Each68788-8070acbb4cd5-0ec3-414a-bac9-e86f69aed8ae12021-10-08
68788-8070-2EA - Each68788-8070c09cf65e-758e-4f65-9d86-5ffa73be179012021-10-08
68788-8070-3EA - Each68788-8070d4f07dd5-3a56-41b5-b55b-8b189977e63712021-10-08
68788-8070-5EA - Each68788-8070b5fcdd41-452f-43a3-b2bb-df4ce4b3745712021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8070ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS INC.]5Legacy NDC20250508_8f4162e2-d1fa-4ad4-8977-532b4df80781.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8070-56878880700550 TABLET in 1 BOTTLE (68788-8070-5) 50 tablet2021-08-230000-00-00NoNoCurrent