FDA.reportPublic FDA data

DURLAZA

Product NDC
58487-001
11-digit product format
584870001
Labeler code
58487
Product ID
58487-001_6461fd18-6b4d-809a-73f4-fd0c23a99291
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetylsalicylic Acid
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
New Haven Pharmaceuticals, Inc.
Application
NDA200671
Marketing category
NDA
Marketing start
2015-09-25
Marketing end
0000-00-00
Substance
ASPIRIN
Active strength
163 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]
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
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58487-001-012020-01-31C16284748780-19d75b9d0-a79b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DURLAZA ™ safely and effectively. See full prescribing information for DURLAZA. DURLAZA (aspirin) Extended Release Capsules, for oral use Initial U.S. Approval:2015
58487-001-022020-01-31C16284748780-19d75b9d0-a79b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DURLAZA ™ safely and effectively. See full prescribing information for DURLAZA. DURLAZA (aspirin) Extended Release Capsules, for oral use Initial U.S. Approval:2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58487-001-01DURLAZA30 in 1 BOTTLECAPSULE, EXTENDED RELEASE306
58487-001-02DURLAZA90 in 1 BOTTLECAPSULE, EXTENDED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58487-001-01EA - Each58487-00128da98b6-40cc-4572-9e78-c75d1a21a6b112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AspirinACTIVE INGREDIENTR16CO5Y76EDURLAZA (ACETYLSALICYLIC ACID) CAPSULE, EXTENDED RELEASE [NEW HAVEN PHARMACEUTICALS, INC.]6
AspirinACTIVE MOIETYR16CO5Y76EDURLAZA (ACETYLSALICYLIC ACID) CAPSULE, EXTENDED RELEASE [NEW HAVEN PHARMACEUTICALS, INC.]6
Castor OilINACTIVE INGREDIENTD5340Y2I9GDURLAZA (ACETYLSALICYLIC ACID) CAPSULE, EXTENDED RELEASE [NEW HAVEN PHARMACEUTICALS, INC.]6
EthylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BDURLAZA (ACETYLSALICYLIC ACID) CAPSULE, EXTENDED RELEASE [NEW HAVEN PHARMACEUTICALS, INC.]6
GelatinINACTIVE INGREDIENT2G86QN327LDURLAZA (ACETYLSALICYLIC ACID) CAPSULE, EXTENDED RELEASE [NEW HAVEN PHARMACEUTICALS, INC.]6
Magnesium StearateINACTIVE INGREDIENT70097M6I30DURLAZA (ACETYLSALICYLIC ACID) CAPSULE, EXTENDED RELEASE [NEW HAVEN PHARMACEUTICALS, INC.]6
PovidonesINACTIVE INGREDIENTFZ989GH94EDURLAZA (ACETYLSALICYLIC ACID) CAPSULE, EXTENDED RELEASE [NEW HAVEN PHARMACEUTICALS, INC.]6
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4DURLAZA (ACETYLSALICYLIC ACID) CAPSULE, EXTENDED RELEASE [NEW HAVEN PHARMACEUTICALS, INC.]6
TalcINACTIVE INGREDIENT7SEV7J4R1UDURLAZA (ACETYLSALICYLIC ACID) CAPSULE, EXTENDED RELEASE [NEW HAVEN PHARMACEUTICALS, INC.]6
Tartaric AcidINACTIVE INGREDIENTW4888I119HDURLAZA (ACETYLSALICYLIC ACID) CAPSULE, EXTENDED RELEASE [NEW HAVEN PHARMACEUTICALS, INC.]6
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPDURLAZA (ACETYLSALICYLIC ACID) CAPSULE, EXTENDED RELEASE [NEW HAVEN PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58487-001DURLAZA (ACETYLSALICYLIC ACID) CAPSULE, EXTENDED RELEASE [NEW HAVEN PHARMACEUTICALS, INC.]6Legacy NDC, 2 package rows20151015_4c2a1403-3862-1efd-0a91-444989222b37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665356aspirin 162.5 MG 24HR Extended Release Oral CapsulePSN4c2a1403-3862-1efd-0a91-444989222b376
1665362Durlaza 162.5 MG 24HR Extended Release Oral CapsulePSN4c2a1403-3862-1efd-0a91-444989222b376
166536224 HR aspirin 162.5 MG Extended Release Oral Capsule [Durlaza]SBD4c2a1403-3862-1efd-0a91-444989222b376
166535624 HR aspirin 162.5 MG Extended Release Oral CapsuleSCD4c2a1403-3862-1efd-0a91-444989222b376
166535624 HR ASA 162.5 MG Extended Release Oral CapsuleSY4c2a1403-3862-1efd-0a91-444989222b376
166536224 HR ASA 162.5 MG Extended Release Oral Capsule [Durlaza]SY4c2a1403-3862-1efd-0a91-444989222b376
1665356aspirin 162.5 MG 24HR Extended Release Oral CapsuleSY4c2a1403-3862-1efd-0a91-444989222b376
1665362Durlaza 162.5 MG 24HR Extended Release Oral CapsuleSY4c2a1403-3862-1efd-0a91-444989222b376

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58487-001-015848700010130 in 1 BOTTLEHistorical
58487-001-025848700010290 in 1 BOTTLEHistorical