Diclofenac Sodium

Product NDC
50436-6924
11-digit product format
504366924
Labeler code
50436
Product ID
50436-6924_b58508c4-66a0-4f7c-b2c8-f0f49aa791ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077863
Marketing category
ANDA
Marketing start
2008-08-19
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
75 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
No
Listing certified through
2020-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-6924-1Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE305
50436-6924-2Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-6924-1EA - Each50436-6924b32a15e8-ab92-4b0a-ae73-81edddcfe40e12012-07-24
50436-6924-2EA - Each50436-692400ee58fd-e4f1-4991-9bea-8af84bd132f812013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diclofenac SodiumACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
DiclofenacACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
magnesium stearateINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
povidoneINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
talcINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
waterINACTIVE INGREDIENT059QF0KO0RDICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6924DICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]5Legacy NDC, 2 package rows20170424_f0e00d55-02b7-4642-a60e-6a5841932ca5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNf0e00d55-02b7-4642-a60e-6a5841932ca55
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDf0e00d55-02b7-4642-a60e-6a5841932ca55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6924-15043669240130 in 1 BOTTLEHistorical
50436-6924-25043669240260 in 1 BOTTLEHistorical