Enteric coated aspirin

Product NDC
68016-722
Requested package NDC
68016-722-12
11-digit product format
680160722
Labeler code
68016
Product ID
68016-722_ed7463b7-0ec1-7b6f-e053-2995a90ae5f5
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-04-01
Marketing end
0000-00-00
Substance
ASPIRIN
Active strength
325 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
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 packagepackage68016-72268016-722-12DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68016-72268016-722-12DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-72268016-722-12DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
68016-722-12EA - Each68016-7220e2ff808-905a-4170-9a0e-ee629f6e314712022-06-06
68016-722-30EA - Each68016-722695f359f-8234-4584-90ac-b0f78ff1773a12022-06-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-722-12680160722121 BOTTLE in 1 CARTON (68016-722-12) > 125 TABLET, COATED in 1 BOTTLE1 bottle2015-04-010000-00-00NoNoCurrent