FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
10544-923
11-digit product format
105440923
Labeler code
10544
Product ID
10544-923_7d011916-630b-4edc-9173-a70e6ad6d808
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA074514
Marketing category
ANDA
Marketing start
2015-05-18
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
50 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
10544-923-142020-01-31C16284748780-19d75b9d0-a720-f424-e053-dadaa90a57ceDICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 40-9184 Revised – August 2015 Rx Only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-923-14Diclofenac Sodium14 in 1 BOTTLETABLET, DELAYED RELEASE142

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-923DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20151029_96edaa7d-8c1c-46d1-8e80-b51072e55ed9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN96edaa7d-8c1c-46d1-8e80-b51072e55ed92
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD96edaa7d-8c1c-46d1-8e80-b51072e55ed92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-923-141054409231414 in 1 BOTTLEHistorical