FDA.reportPublic FDA data

FENOPROFEN CALCIUM

Product NDC
69336-124
11-digit product format
693360124
Labeler code
69336
Product ID
69336-124_81a0da5b-6078-413e-b6d0-d31c1073b3f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOPROFEN CALCIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
Sterling Knight Pharmaceuticals
Application
NDA017604
Marketing category
NDA
Marketing start
2016-07-06
Marketing end
0000-00-00
Substance
FENOPROFEN CALCIUM
Active strength
200 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
2021-12-31
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
69336-124-102022-01-28C16284748780-1d6a99b39-edeb-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use FENOPROFEN CALCIUM safely and effectively. See full prescribing information for Fenoprofen Calcium. FENOPROFEN CALCIUM, USP capsules, for oral use Initial U.S. Approval: 1982

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69336-124-10FENOPROFEN CALCIUM100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69336-124-10EA - Each69336-124a0a86aae-64f7-4be5-8161-daa94e21cef412018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69336-124FENOPROFEN CALCIUM CAPSULE [STERLING KNIGHT PHARMACEUTICALS]3Legacy NDC, 1 package rows20200125_f85ed255-fc1a-4202-a61c-857936c4c868.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197694fenoprofen calcium 200 MG Oral CapsulePSNf85ed255-fc1a-4202-a61c-857936c4c8683
197694fenoprofen 200 MG Oral CapsuleSCDf85ed255-fc1a-4202-a61c-857936c4c8683
197694fenoprofen (as fenoprofen calcium) 200 MG Oral CapsuleSYf85ed255-fc1a-4202-a61c-857936c4c8683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69336-124-1069336012410100 CAPSULE in 1 BOTTLE (69336-124-10) 100 capsule2016-07-060000-00-00NoNoCurrent