FDA.reportPublic FDA data

Diclofenac Sodium Extended-Release

Product NDC
21695-040
11-digit product format
216950040
Labeler code
21695
Product ID
21695-040_51b4f63e-03fd-40f4-804b-39fd80842fd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA075910
Marketing category
ANDA
Marketing start
2002-01-07
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
21695-040-302019-09-24C16284748780-1934fe258-4bd2-48b1-e053-8cdaa90a720aDICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP
21695-040-602019-09-24C16284748780-1934fe258-4bd2-48b1-e053-8cdaa90a720aDICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP
21695-040-902019-09-24C16284748780-1934fe258-4bd2-48b1-e053-8cdaa90a720aDICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-040-30Diclofenac Sodium Extended-Release30 in 1 BOTTLETABLET, EXTENDED RELEASE301
21695-040-60Diclofenac Sodium Extended-Release60 in 1 BOTTLETABLET, EXTENDED RELEASE601
21695-040-90Diclofenac Sodium Extended-Release90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-040-30EA - Each21695-040328063c6-4753-48f4-8d4b-c5cd0414e1d512012-07-24
21695-040-60EA - Each21695-0409899cd51-b551-4fa8-880e-48f1843f6efb12012-07-24
21695-040-90EA - Each21695-040c73262d7-5c27-49d7-b235-9879aa9bb9df12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diclofenac SodiumACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
DiclofenacACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
hypromelloseINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
povidoneINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
talcINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
triacetinINACTIVE INGREDIENTXHX3C3X673DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-040DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 3 package rows20100202_688fa1d0-6e17-4191-8618-8f62bc7765d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSN688fa1d0-6e17-4191-8618-8f62bc7765d31
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCD688fa1d0-6e17-4191-8618-8f62bc7765d31
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSY688fa1d0-6e17-4191-8618-8f62bc7765d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-040-302169500403030 in 1 BOTTLEHistorical
21695-040-602169500406060 in 1 BOTTLEHistorical
21695-040-902169500409090 in 1 BOTTLEHistorical