FDA.reportPublic FDA data

Aggrenox

Product NDC
68151-3971
11-digit product format
681513971
Labeler code
68151
Product ID
68151-3971_b085f4e8-f461-454e-9aff-4f18d9888a8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aspirin and dipyridamole
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA020884
Marketing category
NDA
Marketing start
1999-12-19
Marketing end
0000-00-00
Substance
ASPIRIN; DIPYRIDAMOLE
Active strength
25 mg/1; mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
3285f096-1048-1647-9b36-a2e0f5b56c6cProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
9ab2f788-fb50-9b8e-e14c-49841b1b5968Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-3971-62020-01-31C16284748780-19d75b9d0-4ca8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AGGRENOX safely and effectively. See full prescribing information for AGGRENOX. AGGRENOX® (aspirin/extended-release dipyridamole) Capsules Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-3971-6Aggrenox1 in 1 PACKAGECAPSULE, EXTENDED RELEASE13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
aspirinACTIVE INGREDIENTR16CO5Y76EAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
dipyridamoleACTIVE INGREDIENT64ALC7F90CAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
aspirinACTIVE MOIETYR16CO5Y76EAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
dipyridamoleACTIVE MOIETY64ALC7F90CAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-3971AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160808_f07c8535-f9fb-4697-9b63-1ab22210efc9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362082Aggrenox 25 MG / 200 MG 12HR Extended Release Oral CapsulePSNf07c8535-f9fb-4697-9b63-1ab22210efc93
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsulePSNf07c8535-f9fb-4697-9b63-1ab22210efc93
136208212 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral Capsule [Aggrenox]SBDf07c8535-f9fb-4697-9b63-1ab22210efc93
25908112 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral CapsuleSCDf07c8535-f9fb-4697-9b63-1ab22210efc93
25908112 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral CapsuleSYf07c8535-f9fb-4697-9b63-1ab22210efc93
136208212 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral Capsule [Aggrenox]SYf07c8535-f9fb-4697-9b63-1ab22210efc93
1362082Aggrenox 25/200 (aspirin 25 MG / dipyridamole 200 MG) 12HR Extended Release Oral CapsuleSYf07c8535-f9fb-4697-9b63-1ab22210efc93
1362082Aggrenox 25/200 12HR Extended Release Oral CapsuleSYf07c8535-f9fb-4697-9b63-1ab22210efc93
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsuleSYf07c8535-f9fb-4697-9b63-1ab22210efc93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-3971-6681513971061 in 1 PACKAGEHistorical