FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
52959-423
11-digit product format
529590423
Labeler code
52959
Product ID
52959-423_6029c68a-8374-48c7-8690-74347e623cfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
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
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
52959-423-022019-11-13C16284748780-197449f38-cfe9-f6ea-e053-dbdaa90aa703Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-102019-11-13C16284748780-197449f38-cfe9-f6ea-e053-dbdaa90aa703Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-142019-11-13C16284748780-197449f38-cfe9-f6ea-e053-dbdaa90aa703Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-152019-11-13C16284748780-197449f38-cfe9-f6ea-e053-dbdaa90aa703Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-202019-11-13C16284748780-197449f38-cfe9-f6ea-e053-dbdaa90aa703Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-212019-11-13C16284748780-197449f38-cfe9-f6ea-e053-dbdaa90aa703Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-282019-11-13C16284748780-197449f38-cfe9-f6ea-e053-dbdaa90aa703Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-302019-11-13C16284748780-197449f38-cfe9-f6ea-e053-dbdaa90aa703Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-602019-11-13C16284748780-197449f38-cfe9-f6ea-e053-dbdaa90aa703Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-902019-11-13C16284748780-197449f38-cfe9-f6ea-e053-dbdaa90aa703Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-423-02Diclofenac Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE1203
52959-423-10Diclofenac Sodium10 in 1 BOTTLETABLET, DELAYED RELEASE103
52959-423-14Diclofenac Sodium14 in 1 BOTTLETABLET, DELAYED RELEASE143
52959-423-15Diclofenac Sodium15 in 1 BOTTLETABLET, DELAYED RELEASE153
52959-423-20Diclofenac Sodium20 in 1 BOTTLETABLET, DELAYED RELEASE203
52959-423-21Diclofenac Sodium21 in 1 BOTTLETABLET, DELAYED RELEASE213
52959-423-28Diclofenac Sodium28 in 1 BOTTLETABLET, DELAYED RELEASE283
52959-423-30Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE303
52959-423-60Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE603
52959-423-90Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-423-02EA - Each52959-4236aeae13b-2492-4e3b-90e5-ef0ff0089a5312012-07-24
52959-423-10EA - Each52959-42336f037b6-c112-4e4b-b1bd-0d2bfb42ef3e12012-07-24
52959-423-14EA - Each52959-423ed40fd3b-b59d-4b6d-b4e4-b234c281591012012-07-24
52959-423-15EA - Each52959-42382d6b8fb-837a-46d7-bebc-cab8c07c0e2012012-07-24
52959-423-20EA - Each52959-42332b7de43-f629-46c2-9373-ddd19f448ec812012-07-24
52959-423-21EA - Each52959-42330cbc155-459a-40c9-ac36-236b7a86849f12012-07-24
52959-423-28EA - Each52959-423dc23485c-011e-4588-8204-f08f20f3a10c12012-07-24
52959-423-30EA - Each52959-423db070345-5079-461a-8cdf-4919d00837fd12012-07-24
52959-423-60EA - Each52959-4232a759f35-9f99-4ae7-873f-ba2e049646dd12012-07-24
52959-423-90EA - Each52959-4233065b401-3f9b-4f33-b123-718d74ee8d0512012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-423DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 10 package rows20120423_e424b30d-8f40-48b7-bb99-415f92d84ed0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNe424b30d-8f40-48b7-bb99-415f92d84ed03
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDe424b30d-8f40-48b7-bb99-415f92d84ed03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-423-0252959042302120 in 1 BOTTLEHistorical
52959-423-105295904231010 in 1 BOTTLEHistorical
52959-423-145295904231414 in 1 BOTTLEHistorical
52959-423-155295904231515 in 1 BOTTLEHistorical
52959-423-205295904232020 in 1 BOTTLEHistorical
52959-423-215295904232121 in 1 BOTTLEHistorical
52959-423-285295904232828 in 1 BOTTLEHistorical
52959-423-305295904233030 in 1 BOTTLEHistorical
52959-423-605295904236060 in 1 BOTTLEHistorical
52959-423-905295904239090 in 1 BOTTLEHistorical