FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
0591-0676
11-digit product format
005910676
Labeler code
0591
Product ID
0591-0676_d0c01e3f-d243-420f-bc47-e31141459e12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA076201
Marketing category
ANDA
Marketing start
2002-11-06
Marketing end
2019-10-31
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
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0676-01EA - Each0591-0676df52802a-fb3a-45a5-a444-62244ee7225c12013-02-13

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
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
ACACIAINACTIVE INGREDIENT5C5403N26ODICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
SUCROSEINACTIVE INGREDIENTC151H8M554DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]1

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
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNaa20910b-c01e-454c-9224-1226e7c97c0b7
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDaa20910b-c01e-454c-9224-1226e7c97c0b7
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYaa20910b-c01e-454c-9224-1226e7c97c0b7
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSN7cf9cdc3-6837-4b64-b967-9d15f3b0bdc41
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNd3688090-07ca-4802-a865-60843b0d83ab1
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCD7cf9cdc3-6837-4b64-b967-9d15f3b0bdc41
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDd3688090-07ca-4802-a865-60843b0d83ab1
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSY7cf9cdc3-6837-4b64-b967-9d15f3b0bdc41
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYd3688090-07ca-4802-a865-60843b0d83ab1