YOSPRALA

Product NDC
70347-081
11-digit product format
703470081
Labeler code
70347
Product ID
70347-081_eb6e5371-d9fb-4b94-9e1e-224d8cf9f7e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aspirin and Omeprazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aralez Pharmaceuticals Us Inc.
Application
NDA205103
Marketing category
NDA
Marketing start
2016-09-14
Marketing end
0000-00-00
Substance
ASPIRIN; OMEPRAZOLE
Active strength
81 mg/1; mg/1
Pharmacologic classes
Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70347-081-30YOSPRALA30 in 1 BOTTLETABLET, FILM COATED304
70347-081-90YOSPRALA90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70347-081-30EA - Each70347-081b62d3d2b-d8a9-4596-9ca8-1aff5c04547d12016-10-06
70347-081-90EA - Each70347-081a3baa60c-8d63-42a5-9629-ac6b81edade912016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70347-081YOSPRALA (ASPIRIN AND OMEPRAZOLE) TABLET, FILM COATED [ARALEZ PHARMACEUTICALS US INC.]4Legacy NDC, 2 package rows20180622_73f74f6d-e624-4551-8924-1c747ffb2140.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1811632aspirin 325 MG / omeprazole 40 MG Delayed Release Oral TabletPSN73f74f6d-e624-4551-8924-1c747ffb21404
1811631aspirin 81 MG / omeprazole 40 MG Delayed Release Oral TabletPSN73f74f6d-e624-4551-8924-1c747ffb21404
1811916Yosprala 325 MG / 40 MG Delayed Release Oral TabletPSN73f74f6d-e624-4551-8924-1c747ffb21404
1811918Yosprala 81 MG / 40 MG Delayed Release Oral TabletPSN73f74f6d-e624-4551-8924-1c747ffb21404
1811916aspirin 325 MG / omeprazole 40 MG Delayed Release Oral Tablet [Yosprala]SBD73f74f6d-e624-4551-8924-1c747ffb21404
1811918aspirin 81 MG / omeprazole 40 MG Delayed Release Oral Tablet [Yosprala]SBD73f74f6d-e624-4551-8924-1c747ffb21404
1811632aspirin 325 MG / omeprazole 40 MG Delayed Release Oral TabletSCD73f74f6d-e624-4551-8924-1c747ffb21404
1811631aspirin 81 MG / omeprazole 40 MG Delayed Release Oral TabletSCD73f74f6d-e624-4551-8924-1c747ffb21404
1811632ASA 325 MG / Omeprazole 40 MG Delayed Release Oral TabletSY73f74f6d-e624-4551-8924-1c747ffb21404
1811916ASA 325 MG / Omeprazole 40 MG Delayed Release Oral Tablet [Yosprala]SY73f74f6d-e624-4551-8924-1c747ffb21404
1811631ASA 81 MG / Omeprazole 40 MG Delayed Release Oral TabletSY73f74f6d-e624-4551-8924-1c747ffb21404
1811918ASA 81 MG / Omeprazole 40 MG Delayed Release Oral Tablet [Yosprala]SY73f74f6d-e624-4551-8924-1c747ffb21404
1811916Yosprala (aspirin 325 MG (delayed-release) / omeprazole 40 MG (immediate-release)) Delayed Release Oral TabletSY73f74f6d-e624-4551-8924-1c747ffb21404
1811918Yosprala (aspirin 81 MG (delayed-release) / omeprazole 40 MG (immediate-release)) Delayed Release Oral TabletSY73f74f6d-e624-4551-8924-1c747ffb21404

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
70347-081-307034700813030 in 1 BOTTLEHistorical
70347-081-907034700819090 in 1 BOTTLEHistorical