FDA.reportPublic FDA data

Regular Strength Enteric coated aspirin

Product NDC
80136-921
Requested package NDC
80136-921-01
11-digit product format
801360921
Labeler code
80136
Product ID
80136-921_ed73e161-0b0a-9ec1-e053-2995a90a351a
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
NORTHEAST PHARMA
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2000-07-01
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 packagepackage80136-92180136-921-01IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80136-921-01Regular Strength Enteric coated aspirin100 in 1 BOTTLETABLET, COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80136-921REGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [NORTHEAST PHARMA]3Legacy NDC, 1 package rows20231031_d21961a9-133d-0e72-e053-2a95a90a503c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSNd21961a9-133d-0e72-e053-2a95a90a503c3
198467aspirin 325 MG Delayed Release Oral TabletSCDd21961a9-133d-0e72-e053-2a95a90a503c3
198467ASA 325 MG Delayed Release Oral TabletSYd21961a9-133d-0e72-e053-2a95a90a503c3
198467aspirin 325 MG Enteric Coated Oral TabletSYd21961a9-133d-0e72-e053-2a95a90a503c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80136-921-0180136092101100 TABLET, COATED in 1 BOTTLE (80136-921-01) 2021-09-010000-00-00NoNoCurrent