FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
66336-238
11-digit product format
663360238
Labeler code
66336
Product ID
66336-238_ef637460-8812-461e-a394-21a610bbebd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA074514
Marketing category
ANDA
Marketing start
1996-03-26
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
66336-238-202019-11-27C16284748780-19855e2a2-4bcf-60a7-e053-dbdaa90a05bdDiclofenac Sodium Delayed-release Tablets, USP 40-9184 Revised – June 2012
66336-238-302019-11-27C16284748780-19855e2a2-4bcf-60a7-e053-dbdaa90a05bdDiclofenac Sodium Delayed-release Tablets, USP 40-9184 Revised – June 2012
66336-238-602019-11-27C16284748780-19855e2a2-4bcf-60a7-e053-dbdaa90a05bdDiclofenac Sodium Delayed-release Tablets, USP 40-9184 Revised – June 2012
66336-238-902019-11-27C16284748780-19855e2a2-4bcf-60a7-e053-dbdaa90a05bdDiclofenac Sodium Delayed-release Tablets, USP 40-9184 Revised – June 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-238-20Diclofenac Sodium20 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE202
66336-238-30Diclofenac Sodium30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE302
66336-238-60Diclofenac Sodium60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE602
66336-238-90Diclofenac Sodium90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66336-238-20EA - Each66336-2389ca2c285-23fe-4bc6-b501-432499933eff12013-11-04
66336-238-60EA - Each66336-23899cb8789-7e6d-4058-8851-ec34e84b16b412013-11-04

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-238DICLOFENAC SODIUM TABLET, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 4 package rows20131029_1877c2fb-39f7-45e3-b7f0-eb834ee273e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN1877c2fb-39f7-45e3-b7f0-eb834ee273e42
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD1877c2fb-39f7-45e3-b7f0-eb834ee273e42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-238-206633602382020 in 1 BOTTLE, PLASTICHistorical
66336-238-306633602383030 in 1 BOTTLE, PLASTICHistorical
66336-238-606633602386060 in 1 BOTTLE, PLASTICHistorical
66336-238-906633602389090 in 1 BOTTLE, PLASTICHistorical