FDA.reportPublic FDA data

Fenoprofen Calcium

Product NDC
53217-169
11-digit product format
532170169
Labeler code
53217
Product ID
53217-169_c44a6c19-77e8-48df-8e42-0b7c5681fa84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenoprofen calcium
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
NDA017604
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-05-19
Marketing end
0000-00-00
Substance
FENOPROFEN CALCIUM
Active strength
400 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
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
0916fe0d-58e1-5e07-2471-9a804a1b0628Product name320240514
090af53b-bc54-1ac8-5eee-2f06b5d9cff9Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-169-902020-01-31C16284748780-19d75b9d0-d936-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Fenoprofen Calcium Capsules, USP safely and effectively. See full prescribing information for Fenoprofen Calcium Capsules, USP. Fenoprofen Calcium Capsules, USP for oral use Initial U.S. Approval: 1982

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-169-90Fenoprofen Calcium90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-169-90EA - Each53217-16949e813ac-f628-4fc7-b5a8-60c04feb9a5a12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-169FENOPROFEN CALCIUM CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20170223_7bf7114a-b053-46cc-9e00-dc3cc87b50a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858116fenoprofen calcium 400 MG Oral CapsulePSN7bf7114a-b053-46cc-9e00-dc3cc87b50a91
858116fenoprofen 400 MG Oral CapsuleSCD7bf7114a-b053-46cc-9e00-dc3cc87b50a91
858116fenoprofen (as fenoprofen calcium) 400 MG Oral CapsuleSY7bf7114a-b053-46cc-9e00-dc3cc87b50a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-169-905321701699090 in 1 BOTTLEHistorical