FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
45865-364
11-digit product format
458650364
Labeler code
45865
Product ID
45865-364_f4dc2502-bb11-4c1d-a67d-67ea7785749c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA075910
Marketing category
ANDA
Marketing start
2009-01-05
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
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
45865-364-152019-11-13C16284748780-197449f38-bf2a-f6ea-e053-dbdaa90aa703DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP
45865-364-302019-11-13C16284748780-197449f38-bf2a-f6ea-e053-dbdaa90aa703DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP
45865-364-492019-11-13C16284748780-197449f38-bf2a-f6ea-e053-dbdaa90aa703DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP
45865-364-602019-11-13C16284748780-197449f38-bf2a-f6ea-e053-dbdaa90aa703DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP
45865-364-902019-11-13C16284748780-197449f38-bf2a-f6ea-e053-dbdaa90aa703DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-364-15Diclofenac SodiumExtended-Release15 in 1 BOTTLETABLET, EXTENDED RELEASE152
45865-364-30Diclofenac SodiumExtended-Release30 in 1 BOTTLETABLET, EXTENDED RELEASE302
45865-364-49Diclofenac SodiumExtended-Release100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
45865-364-60Diclofenac SodiumExtended-Release60 in 1 BOTTLETABLET, EXTENDED RELEASE602
45865-364-90Diclofenac SodiumExtended-Release90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
TRIACETININACTIVE INGREDIENTXHX3C3X673DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-364DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 5 package rows20120801_d349b4ca-3aec-44a8-a4d5-87be4c822190.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNd349b4ca-3aec-44a8-a4d5-87be4c8221902
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDd349b4ca-3aec-44a8-a4d5-87be4c8221902
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYd349b4ca-3aec-44a8-a4d5-87be4c8221902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-364-154586503641515 in 1 BOTTLEHistorical
45865-364-304586503643030 in 1 BOTTLEHistorical
45865-364-4945865036449100 in 1 BOTTLEHistorical
45865-364-604586503646060 in 1 BOTTLEHistorical
45865-364-904586503649090 in 1 BOTTLEHistorical