FDA.reportPublic FDA data

Aggrenox

Product NDC
0597-0001
11-digit product format
005970001
Labeler code
0597
Product ID
0597-0001_afbcb310-8722-47df-acac-c5fcb2c4bb2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aspirin and dipyridamole
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals Inc.
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
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],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0001-60EA - Each0597-000129373277-52cb-4af8-b604-4676b6a47cc912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
aspirinACTIVE INGREDIENTR16CO5Y76EAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
aspirinACTIVE INGREDIENTR16CO5Y76EAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
dipyridamoleACTIVE INGREDIENT64ALC7F90CAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
dipyridamoleACTIVE INGREDIENT64ALC7F90CAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
aspirinACTIVE MOIETYR16CO5Y76EAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
aspirinACTIVE MOIETYR16CO5Y76EAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
dipyridamoleACTIVE MOIETY64ALC7F90CAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
dipyridamoleACTIVE MOIETY64ALC7F90CAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
ACACIAINACTIVE INGREDIENT5C5403N26OAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
ALUMINUM STEARATEINACTIVE INGREDIENTU6XF9NP8HMAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
hypromellose phthalate (31% phthalate, 170 cst)INACTIVE INGREDIENT8LDD2V82F5AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
methacrylic acid - methyl methacrylate copolymer (1:1)INACTIVE INGREDIENT74G4R6TH13AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2

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
1362082Aggrenox 25 MG / 200 MG 12HR Extended Release Oral CapsulePSNe729d829-4bd0-4074-85ea-e0f9f5d7cdb52
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsulePSNe729d829-4bd0-4074-85ea-e0f9f5d7cdb52
136208212 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral Capsule [Aggrenox]SBDe729d829-4bd0-4074-85ea-e0f9f5d7cdb52
25908112 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral CapsuleSCDe729d829-4bd0-4074-85ea-e0f9f5d7cdb52
25908112 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral CapsuleSYe729d829-4bd0-4074-85ea-e0f9f5d7cdb52
136208212 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral Capsule [Aggrenox]SYe729d829-4bd0-4074-85ea-e0f9f5d7cdb52
1362082Aggrenox 25/200 (aspirin 25 MG / dipyridamole 200 MG) 12HR Extended Release Oral CapsuleSYe729d829-4bd0-4074-85ea-e0f9f5d7cdb52
1362082Aggrenox 25/200 12HR Extended Release Oral CapsuleSYe729d829-4bd0-4074-85ea-e0f9f5d7cdb52
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsuleSYe729d829-4bd0-4074-85ea-e0f9f5d7cdb52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0001-60005970001601 BOTTLE in 1 CARTON (0597-0001-60) > 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE1 bottle1999-12-190000-00-00NoNoCurrent