FDA.reportPublic FDA data

aspirin 325 MG / omeprazole 40 MG Delayed Release Oral Tablet [Yosprala]

RxCUI
1811916
RxNorm name
aspirin 325 MG / omeprazole 40 MG Delayed Release Oral Tablet [Yosprala]
Display name
YOSPRALA (Oral Pill)
Full name
aspirin 325 MG / omeprazole 40 MG Delayed Release Oral Tablet [Yosprala]
Term type
SBD
Status
Active
Strength
325-40 mg
Dose form
DR Tab
Route
Oral Pill
Updated
2026-10-24 12:49:09

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112016
Active start
112016
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
aspirin325 MG / 1 EACHaspirinaspirin
omeprazole40 MG / 1 EACHomeprazoleomeprazole

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Delayed Release Oral Tablet10312

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
aspirin1191
omeprazole7646

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRASA 325 MG / Omeprazole 40 MG Delayed Release Oral Tablet [Yosprala]1NAMES
RxNorm Nameaspirin 325 MG / omeprazole 40 MG Delayed Release Oral Tablet [Yosprala]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
RxCUI18119161CODES
MMSL_CODEBD310531CODES

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 6 matching rows.

NDC11, Source, Active table
NDC11SourceActive
73568000502rxnav_ndcsyes
64950042530rxnav_historical
64950042590rxnav_historical
70347032530rxnav_historical
70347032590rxnav_historical
71800001630rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
73f74f6d-e624-4551-8924-1c747ffb2140Yosprala 325 MG / 40 MG Delayed Release Oral Tablet [PSN] · aspirin 325 MG / omeprazole 40 MG Delayed Release Oral Tablet [Yosprala] [SBD] · ASA 325 MG / Omeprazole 40 MG Delayed Release Oral Tablet [Yosprala] [SY] · Yosprala (aspirin 325 MG (delayed-release) / omeprazole 40 MG (immediate-release)) Delayed Release Oral Tablet [SY]44These highlights do not include all the information needed to use YOSPRALA safely and effectively. See full prescribing information for YOSPRALA . YOSPRALA (aspirin and omeprazole) delayed-release tablets, for oral use Initial U.S. Approval: 201620180619
bce0eb08-7eac-4437-ba88-fafac350a8f6Yosprala 325 MG / 40 MG Delayed Release Oral Tablet [PSN] · aspirin 325 MG / omeprazole 40 MG Delayed Release Oral Tablet [Yosprala] [SBD] · ASA 325 MG / Omeprazole 40 MG Delayed Release Oral Tablet [Yosprala] [SY] · Yosprala (aspirin 325 MG (delayed-release) / omeprazole 40 MG (immediate-release)) Delayed Release Oral Tablet [SY]41These highlights do not include all the information needed to use YOSPRALA™ safely and effectively. See full prescribing information for YOSPRALA. YOSPRALA (aspirin and omeprazole) delayed-release tablets, for oral use Initial U.S. Approval: 201620200130

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
6a386a07-852f-4b24-878a-1e53317e1717These highlights do not include all the information needed to use YOSPRALA ® safely and effectively. See full prescribing information for YOSPRALA. YOSPRALA (aspirin and omeprazole) delayed-release tablets, for oral use Initial U.S. Approval: 2016Genus Lifesciences Inc. | Patheon Pharmaceucticals20230731
393013a7-03fa-4e83-8bf6-3e2e430c9cf6These highlights do not include all the information needed to use YOSPRALA™ safely and effectively. See full prescribing information for YOSPRALA. YOSPRALA (aspirin and omeprazole) delayed-release tablets, for oral use Initial U.S. Approval: 2016Innovida Phamaceutique Corporation | Patheon Pharmaceucticals20211020
bce0eb08-7eac-4437-ba88-fafac350a8f6These highlights do not include all the information needed to use YOSPRALA™ safely and effectively. See full prescribing information for YOSPRALA. YOSPRALA (aspirin and omeprazole) delayed-release tablets, for oral use Initial U.S. Approval: 2016PHARMACEUTIKA LTD | Patheon Pharmaceucticals20200130
73f74f6d-e624-4551-8924-1c747ffb2140These highlights do not include all the information needed to use YOSPRALA safely and effectively. See full prescribing information for YOSPRALA . YOSPRALA (aspirin and omeprazole) delayed-release tablets, for oral use Initial U.S. Approval: 2016Aralez Pharmaceuticals Us Inc. | ARALEZ PHARMACEUTICALS TRADING DESIGNATED ACTIVITY COMPANY | Patheon Pharmaceuticals Inc.20180619

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCA01ADOther agents for local oral treatmentATC1-4aspirin
ATCB01ACPlatelet aggregation inhibitors excl. heparinATC1-4aspirin
ATCA02BCProton pump inhibitorsATC1-4omeprazole
ATCN02BASalicylic acid and derivativesATC1-4aspirin
FDASPLN0000175722Nonsteroidal Anti-inflammatory DrugEPChas_epcaspirin
FDASPLN0000175578Platelet Aggregation InhibitorEPChas_epcaspirin
FDASPLN0000175525Proton Pump InhibitorEPChas_epcomeprazole
FDASPLN0000182140Cytochrome P450 2C19 InhibitorsMOAhas_moaomeprazole
FDASPLN0000000147Proton Pump InhibitorsMOAhas_moaomeprazole
MEDRTD001241AspirinCHEMhas_ingredientaspirin
MEDRTD009853OmeprazoleCHEMhas_ingredientomeprazole
MEDRTD001172Arthritis, RheumatoidDISEASEmay_treataspirin
MEDRTD001778Blood Coagulation DisordersDISEASEci_withaspirin
MEDRTD001791Blood Platelet DisordersDISEASEci_withaspirin
MEDRTD002544Cerebral InfarctionDISEASEmay_preventaspirin
MEDRTD002644ChickenpoxDISEASEci_withaspirin
MEDRTD002675Child, PreschoolDISEASEci_withaspirin
MEDRTD004342Drug HypersensitivityDISEASEci_withaspirin
MEDRTD004342Drug HypersensitivityDISEASEci_withomeprazole
MEDRTD004381Duodenal UlcerDISEASEmay_treatomeprazole
MEDRTD004941EsophagitisDISEASEmay_treatomeprazole
MEDRTD005334FeverDISEASEmay_treataspirin
MEDRTD005764Gastroesophageal RefluxDISEASEmay_treatomeprazole
MEDRTD006073GoutDISEASEmay_treataspirin
MEDRTD006356HeartburnDISEASEmay_treatomeprazole
MEDRTD016481Helicobacter InfectionsDISEASEmay_treatomeprazole
MEDRTD006396HematemesisDISEASEci_withaspirin
MEDRTD006474Hemorrhagic DisordersDISEASEci_withaspirin
MEDRTD007223InfantDISEASEci_withaspirin
MEDRTD007249InflammationDISEASEmay_treataspirin
MEDRTD002546Ischemic Attack, TransientDISEASEmay_preventaspirin
MEDRTD008551MelenaDISEASEci_withaspirin
MEDRTD009203Myocardial InfarctionDISEASEmay_preventaspirin
MEDRTD009298Nasal PolypsDISEASEci_withaspirin
MEDRTD010003OsteoarthritisDISEASEmay_treataspirin
MEDRTD010146PainDISEASEmay_preventaspirin
MEDRTD010146PainDISEASEmay_treataspirin
MEDRTD011225Pre-EclampsiaDISEASEmay_preventaspirin
MEDRTD011263Pregnancy Trimester, ThirdDISEASEci_withaspirin
MEDRTD012213Rheumatic FeverDISEASEmay_treataspirin
MEDRTD013276Stomach UlcerDISEASEmay_treatomeprazole
MEDRTD015043Zollinger-Ellison SyndromeDISEASEmay_treatomeprazole
MEDRTN0000000160Cyclooxygenase InhibitorsMOAhas_moaaspirin
MEDRTN0000000147Proton Pump InhibitorsMOAhas_moaomeprazole
MEDRTN0000008831Decreased Platelet Activating Factor ProductionPEhas_peaspirin
MEDRTN0000008832Decreased Platelet AggregationPEhas_peaspirin
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peaspirin
MEDRTN0000009006Decreased Thromboxane ProductionPEhas_peaspirin
MEDRTN0000009724Inhibition Gastric Acid SecretionPEhas_peomeprazole
MEDRTN0000000026Hepatic MetabolismPKhas_pkaspirin
MEDRTN0000000026Hepatic MetabolismPKsite_of_metabolismomeprazole
MEDRTN0000000042Renal ExcretionPKhas_pkaspirin

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH325 MG / 40 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable SynonymYosprala 325 MG / 40 MG Delayed Release Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon