FDA.reportPublic FDA data

Aggrenox

Product NDC
21695-656
11-digit product format
216950656
Labeler code
21695
Product ID
21695-656_6473563d-b4df-4434-a74e-f8fa3cb9994f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aspirin and dipyridamole
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp.
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
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-656-602019-09-24C16284748780-1934fe258-4adf-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use Aggrenox Capsules safely and effectively. See full prescribing information for Aggrenox Capsules. AGGRENOX® (aspirin/extended-release dipyridamole) Capsules Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-656-60Aggrenox60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-656-60EA - Each21695-65602b0f367-fd7a-4275-90dd-a8ec5870bf4412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
aspirinACTIVE INGREDIENTR16CO5Y76EAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
dipyridamoleACTIVE INGREDIENT64ALC7F90CAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
aspirinACTIVE MOIETYR16CO5Y76EAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
dipyridamoleACTIVE MOIETY64ALC7F90CAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
acaciaINACTIVE INGREDIENT5C5403N26OAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
aluminum stearateINACTIVE INGREDIENTU6XF9NP8HMAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
gelatinINACTIVE INGREDIENT2G86QN327LAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
hypromelloseINACTIVE INGREDIENT3NXW29V3WOAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
hypromellose phthalate (31% phthalate, 170 cst)INACTIVE INGREDIENT8LDD2V82F5AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
methacrylic acid - methyl methacrylate copolymer (1:1)INACTIVE INGREDIENT74G4R6TH13AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
povidoneINACTIVE INGREDIENTFZ989GH94EAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
sucroseINACTIVE INGREDIENTC151H8M554AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
talcINACTIVE INGREDIENT7SEV7J4R1UAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
tartaric acidINACTIVE INGREDIENTW4888I119HAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
triacetinINACTIVE INGREDIENTXHX3C3X673AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
waterINACTIVE INGREDIENT059QF0KO0RAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-656AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20100908_6473563d-b4df-4434-a74e-f8fa3cb9994f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362082Aggrenox 25 MG / 200 MG 12HR Extended Release Oral CapsulePSN6473563d-b4df-4434-a74e-f8fa3cb9994f1
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsulePSN6473563d-b4df-4434-a74e-f8fa3cb9994f1
136208212 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral Capsule [Aggrenox]SBD6473563d-b4df-4434-a74e-f8fa3cb9994f1
25908112 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral CapsuleSCD6473563d-b4df-4434-a74e-f8fa3cb9994f1
25908112 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral CapsuleSY6473563d-b4df-4434-a74e-f8fa3cb9994f1
136208212 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral Capsule [Aggrenox]SY6473563d-b4df-4434-a74e-f8fa3cb9994f1
1362082Aggrenox 25/200 (aspirin 25 MG / dipyridamole 200 MG) 12HR Extended Release Oral CapsuleSY6473563d-b4df-4434-a74e-f8fa3cb9994f1
1362082Aggrenox 25/200 12HR Extended Release Oral CapsuleSY6473563d-b4df-4434-a74e-f8fa3cb9994f1
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsuleSY6473563d-b4df-4434-a74e-f8fa3cb9994f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-656-602169506566060 in 1 BOTTLEHistorical