FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
24208-457
11-digit product format
242080457
Labeler code
24208
Product ID
24208-457_4965dd94-e9f5-0494-e063-6294a90ac40f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
ANDA078792
Marketing category
ANDA
Marketing start
2007-12-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium
Listing expiration
2027-12-31

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
24208-457-05Diclofenac Sodium1 in 1 CARTONSOLUTION/ DROPS114
24208-457-05Diclofenac Sodium5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS514
24208-457-25Diclofenac Sodium2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.514
24208-457-25Diclofenac Sodium1 in 1 CARTONSOLUTION/ DROPS114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-457-05ML - Milliliter24208-4570756dcb4-9845-4451-b55b-7d10a9730d1012012-07-24
24208-457-25ML - Milliliter24208-45716a64fa3-942f-42a2-a87b-8e17b8e7ad4e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6ODICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BDICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VDICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
WATERINACTIVE INGREDIENT059QF0KO0RDICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6ODICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BDICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VDICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RDICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]1
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6ODICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]1
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6ODICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BDICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BDICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VDICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]1
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VDICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RDICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-457DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]12Current NDC, Legacy NDC, 4 package rows20240726_39dfffb0-612a-48f3-8db5-1a59899b91e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854801diclofenac sodium 0.1 % Ophthalmic SolutionPSN5d74488c-e092-415d-b19b-05318380d9b115
854801diclofenac sodium 1 MG/ML Ophthalmic SolutionSCD5d74488c-e092-415d-b19b-05318380d9b115
854801diclofenac sodium 0.1 % Ophthalmic SolutionSY5d74488c-e092-415d-b19b-05318380d9b115
854801diclofenac sodium 0.1 % Ophthalmic SolutionPSN39dfffb0-612a-48f3-8db5-1a59899b91e914
854801diclofenac sodium 1 MG/ML Ophthalmic SolutionSCD39dfffb0-612a-48f3-8db5-1a59899b91e914
854801diclofenac sodium 0.1 % Ophthalmic SolutionSY39dfffb0-612a-48f3-8db5-1a59899b91e914
854801diclofenac sodium 0.1 % Ophthalmic SolutionPSN6bec35d6-500d-4570-b2ff-ce7b4fc801df2
854801diclofenac sodium 1 MG/ML Ophthalmic SolutionSCD6bec35d6-500d-4570-b2ff-ce7b4fc801df2
854801diclofenac sodium 0.1 % Ophthalmic SolutionSY6bec35d6-500d-4570-b2ff-ce7b4fc801df2
854801diclofenac sodium 0.1 % Ophthalmic SolutionPSN41c80e79-36fd-4b90-bae1-55d6042c3ca21
854801diclofenac sodium 0.1 % Ophthalmic SolutionPSN888d7749-bdbc-4788-a215-9c0447aee79a1
854801diclofenac sodium 1 MG/ML Ophthalmic SolutionSCD41c80e79-36fd-4b90-bae1-55d6042c3ca21
854801diclofenac sodium 1 MG/ML Ophthalmic SolutionSCD888d7749-bdbc-4788-a215-9c0447aee79a1
854801diclofenac sodium 0.1 % Ophthalmic SolutionSY41c80e79-36fd-4b90-bae1-55d6042c3ca21
854801diclofenac sodium 0.1 % Ophthalmic SolutionSY888d7749-bdbc-4788-a215-9c0447aee79a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-457-05242080457051 BOTTLE, DROPPER in 1 CARTON (24208-457-05) / 5 mL in 1 BOTTLE, DROPPER2007-12-280000-00-00NoNoCurrent
24208-457-25242080457251 BOTTLE, DROPPER in 1 CARTON (24208-457-25) / 2.5 mL in 1 BOTTLE, DROPPER2007-12-280000-00-00NoNoCurrent