FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
60505-0406
11-digit product format
605050406
Labeler code
60505
Product ID
60505-0406_623c9522-98af-c9da-47d6-a4b47f54efa2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Apotex Corp.
Application
ANDA207714
Marketing category
ANDA
Marketing start
2022-05-09
Substance
DICLOFENAC SODIUM
Active strength
20 mg/g
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 SODIUM20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui1487074

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0406-3Diclofenac Sodium112 g in 1 BOTTLESOLUTION1125
60505-0406-3Diclofenac Sodium1 in 1 CARTONSOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0406-3GM - Gram60505-0406b5ac1d58-de65-4c9f-9761-13001a1c355612022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0406DICLOFENAC SODIUM SOLUTION [APOTEX CORP.]4Current NDC, Legacy NDC, 2 package rows20240802_9f416595-60b2-c921-5df4-a09d5f6abe71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1487074diclofenac sodium 2 % Topical SolutionPSN9f416595-60b2-c921-5df4-a09d5f6abe715
1487074diclofenac sodium 20 MG/ML Topical SolutionSCD9f416595-60b2-c921-5df4-a09d5f6abe715
1487074diclofenac sodium 2 % Topical SolutionSY9f416595-60b2-c921-5df4-a09d5f6abe715
1487074diclofenac sodium 2 % Topical SolutionPSN4382cc15-8978-4f3b-e063-6394a90a9ecb2
1487074diclofenac sodium 20 MG/ML Topical SolutionSCD4382cc15-8978-4f3b-e063-6394a90a9ecb2
1487074diclofenac sodium 2 % Topical SolutionSY4382cc15-8978-4f3b-e063-6394a90a9ecb2
1487074diclofenac sodium 2 % Topical SolutionPSN31b56330-6870-48b7-a8c4-0639e0766b251
1487074diclofenac sodium 2 % Topical SolutionPSN3d71f76d-bb23-7251-e063-6394a90aa9d81
1487074diclofenac sodium 2 % Topical SolutionPSN41da2e11-58c7-9622-e063-6394a90a9fdb1
1487074diclofenac sodium 20 MG/ML Topical SolutionSCD31b56330-6870-48b7-a8c4-0639e0766b251
1487074diclofenac sodium 20 MG/ML Topical SolutionSCD3d71f76d-bb23-7251-e063-6394a90aa9d81
1487074diclofenac sodium 20 MG/ML Topical SolutionSCD41da2e11-58c7-9622-e063-6394a90a9fdb1
1487074diclofenac sodium 2 % Topical SolutionSY31b56330-6870-48b7-a8c4-0639e0766b251
1487074diclofenac sodium 2 % Topical SolutionSY3d71f76d-bb23-7251-e063-6394a90aa9d81
1487074diclofenac sodium 2 % Topical SolutionSY41da2e11-58c7-9622-e063-6394a90a9fdb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0406-3605050406031 BOTTLE in 1 CARTON (60505-0406-3) / 112 g in 1 BOTTLE1 bottle2022-05-090000-00-00NoNoCurrent