FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
21695-710
11-digit product format
216950710
Labeler code
21695
Product ID
21695-710_888d7749-bdbc-4788-a215-9c0447aee79a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
Application
ANDA078792
Marketing category
ANDA
Marketing start
2007-12-28
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
1 mg/mL
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
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
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
21695-710-052019-09-24C16284748780-1934fe258-4a04-48b1-e053-8cdaa90a720aDiclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)
21695-710-252019-09-24C16284748780-1934fe258-4a04-48b1-e053-8cdaa90a720aDiclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-710-05Diclofenac Sodium1 in 1 CARTONSOLUTION/ DROPS11
21695-710-05Diclofenac Sodium5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS51
21695-710-25Diclofenac Sodium1 in 1 CARTONSOLUTION/ DROPS11
21695-710-25Diclofenac Sodium2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-710-05ML - Milliliter21695-7101aca9bb0-07ea-4e7e-b0ed-a50b01546f1112012-07-24
21695-710-25ML - Milliliter21695-71048626f9f-1d08-48fd-9e13-7a0735af771d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6ODICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BDICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VDICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RDICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-710DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20101123_888d7749-bdbc-4788-a215-9c0447aee79a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854801diclofenac sodium 0.1 % Ophthalmic SolutionPSN888d7749-bdbc-4788-a215-9c0447aee79a1
854801diclofenac sodium 1 MG/ML Ophthalmic SolutionSCD888d7749-bdbc-4788-a215-9c0447aee79a1
854801diclofenac sodium 0.1 % Ophthalmic SolutionSY888d7749-bdbc-4788-a215-9c0447aee79a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-710-05216950710051 in 1 CARTONHistorical
21695-710-25216950710251 in 1 CARTONHistorical