FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
10544-928
11-digit product format
105440928
Labeler code
10544
Product ID
10544-928_219d225c-a0fb-748a-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA076201
Marketing category
ANDA
Marketing start
2015-06-02
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
10544-928-072020-01-31C16284748780-19d75b9d0-fe4a-f424-e053-dadaa90a57ceDiclofenac Sodium Extended-release Tablets
10544-928-142020-01-31C16284748780-19d75b9d0-fe4a-f424-e053-dadaa90a57ceDiclofenac Sodium Extended-release Tablets
10544-928-302020-01-31C16284748780-19d75b9d0-fe4a-f424-e053-dadaa90a57ceDiclofenac Sodium Extended-release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-928-07Diclofenac Sodium7 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE78
10544-928-14Diclofenac Sodium14 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE148
10544-928-30Diclofenac Sodium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE308

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8
ACACIAINACTIVE INGREDIENT5C5403N26ODICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8
POVIDONEINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8
SUCROSEINACTIVE INGREDIENTC151H8M554DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-928DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]8Legacy NDC, 3 package rows20151008_753dd45e-7135-438a-9aa7-990cf5f97c6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSN753dd45e-7135-438a-9aa7-990cf5f97c6d8
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCD753dd45e-7135-438a-9aa7-990cf5f97c6d8
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSY753dd45e-7135-438a-9aa7-990cf5f97c6d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-928-07105440928077 in 1 BOTTLE, PLASTICHistorical
10544-928-141054409281414 in 1 BOTTLE, PLASTICHistorical
10544-928-301054409283030 in 1 BOTTLE, PLASTICHistorical