FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
61314-014
11-digit product format
613140014
Labeler code
61314
Product ID
61314-014_202278f8-31f7-4c24-ae96-8065430d6a7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
ANDA078031
Marketing category
ANDA
Marketing start
2008-02-14
Substance
DICLOFENAC SODIUM
Active strength
1 mg/mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui854801

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-014-05Diclofenac Sodium5 mL in 1 BOTTLESOLUTION57
61314-014-05Diclofenac Sodium1 in 1 CARTONSOLUTION17
61314-014-25Diclofenac Sodium1 in 1 CARTONSOLUTION17
61314-014-25Diclofenac Sodium2.5 mL in 1 BOTTLESOLUTION2.57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-014-05ML - Milliliter61314-014a52f7e4c-3267-4c4c-8e38-2cb6d944257312012-07-24
61314-014-25ML - Milliliter61314-014ab7d2340-c8c7-4e03-baa1-a023f9f720a112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM SOLUTION [SANDOZ INC]2
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM SOLUTION [SANDOZ INC]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4DICLOFENAC SODIUM SOLUTION [SANDOZ INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDICLOFENAC SODIUM SOLUTION [SANDOZ INC]2
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6ODICLOFENAC SODIUM SOLUTION [SANDOZ INC]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BDICLOFENAC SODIUM SOLUTION [SANDOZ INC]2
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VDICLOFENAC SODIUM SOLUTION [SANDOZ INC]2
WATERINACTIVE INGREDIENT059QF0KO0RDICLOFENAC SODIUM SOLUTION [SANDOZ INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-014DICLOFENAC SODIUM SOLUTION [SANDOZ INC]7Current NDC, Legacy NDC, 4 package rows20241206_52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854801diclofenac sodium 0.1 % Ophthalmic SolutionPSN52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b7
854801diclofenac sodium 1 MG/ML Ophthalmic SolutionSCD52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b7
854801diclofenac sodium 0.1 % Ophthalmic SolutionSY52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b7
854801diclofenac sodium 0.1 % Ophthalmic SolutionPSN3a520306-fe3e-4830-963f-04b080db3abc6
854801diclofenac sodium 1 MG/ML Ophthalmic SolutionSCD3a520306-fe3e-4830-963f-04b080db3abc6
854801diclofenac sodium 0.1 % Ophthalmic SolutionSY3a520306-fe3e-4830-963f-04b080db3abc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-014-05613140014051 BOTTLE in 1 CARTON (61314-014-05) / 5 mL in 1 BOTTLE1 bottle2018-02-140000-00-00NoNoCurrent
61314-014-25613140014251 BOTTLE in 1 CARTON (61314-014-25) / 2.5 mL in 1 BOTTLE1 bottle2018-02-140000-00-00NoNoCurrent