ACETAMINOPHEN

Product NDC
0615-8409
Requested package NDC
0615-8409-30
11-digit product format
006158409
Labeler code
0615
Product ID
0615-8409_fc6ccc87-6e4a-40a5-8af2-479db1c618f8
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-07-18
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 packagepackage0615-84090615-8409-30DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8409ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]13Legacy NDC20240820_7fae4caf-a8aa-442e-97ee-0465577bdb87.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8409-30006158409306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8409-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2021-10-060000-00-00NoNoCurrent