FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
0781-1787
11-digit product format
007811787
Labeler code
0781
Product ID
0781-1787_f1ed77db-81fa-4a9e-8a1f-f98129b2a087
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA074376
Marketing category
ANDA
Marketing start
1995-09-28
Marketing end
2019-08-31
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
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
0781-1787-01EA - Each0781-17872ab648d1-95d2-4b62-af36-24da8cad673012012-07-24
0781-1787-10EA - Each0781-17879728d605-1313-47c6-ad21-bfe250866bfc12012-07-24
0781-1787-60EA - Each0781-178703d2489b-f8ad-470e-821e-46a3f08a726c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
Diclofenac SodiumACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA]2
diclofenacACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA]2
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71ODICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855664diclofenac sodium 25 MG Delayed Release Oral TabletPSNbd27460e-46ff-4450-a4f2-a41420c1f93d2
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNbd27460e-46ff-4450-a4f2-a41420c1f93d2
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNd207da6e-d074-4dab-95f1-265b1df41aea2
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNbd27460e-46ff-4450-a4f2-a41420c1f93d2
855664diclofenac sodium 25 MG Delayed Release Oral TabletSCDbd27460e-46ff-4450-a4f2-a41420c1f93d2
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDbd27460e-46ff-4450-a4f2-a41420c1f93d2
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDd207da6e-d074-4dab-95f1-265b1df41aea2
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDbd27460e-46ff-4450-a4f2-a41420c1f93d2