FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
33358-451
11-digit product format
333580451
Labeler code
33358
Product ID
33358-451_fb0dcb02-f3ac-4d81-9036-3896ea929348
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
RxChange Co.
Application
NDA020254
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-11-26
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
100 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [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
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33358-451-302020-01-31C16284748780-19d75b9d0-0ebf-f424-e053-dadaa90a57ceDiclofenac Sodium Extended-Release Tablets, USP Tablets of 100 mg Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33358-451-30Diclofenac Sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33358-451-30EA - Each33358-45122e79c2e-4bd0-468c-9503-66672b3bb22412015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2
SUCROSEINACTIVE INGREDIENTC151H8M554DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33358-451DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2Legacy NDC, 1 package rows20141202_01e92b73-8271-4028-8a74-c236e3b55db8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSN01e92b73-8271-4028-8a74-c236e3b55db82
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCD01e92b73-8271-4028-8a74-c236e3b55db82
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSY01e92b73-8271-4028-8a74-c236e3b55db82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33358-451-303335804513030 in 1 BOTTLEHistorical