FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
51672-1369
11-digit product format
516721369
Labeler code
51672
Product ID
51672-1369_399509a1-ef56-a062-e063-6294a90aa3b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA208098
Marketing category
ANDA
Marketing start
2023-05-31
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
51672-1369-8Diclofenac Sodium112 g in 1 BOTTLE, PUMPSOLUTION11211
51672-1369-8Diclofenac Sodium1 in 1 CARTONSOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1369-8GM - Gram51672-1369c4cf4756-9972-406b-93af-43cdf3272a7812023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1369DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]9Current NDC, Legacy NDC, 2 package rows20241208_f9a0c654-5f77-430f-b921-295eb776cbcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1487074diclofenac sodium 2 % Topical SolutionPSN942b4a76-1029-4cd7-9def-531ed33f3053100
1487074diclofenac sodium 20 MG/ML Topical SolutionSCD942b4a76-1029-4cd7-9def-531ed33f3053100
1487074diclofenac sodium 2 % Topical SolutionSY942b4a76-1029-4cd7-9def-531ed33f3053100
1487074diclofenac sodium 2 % Topical SolutionPSNf9a0c654-5f77-430f-b921-295eb776cbcd11
1487074diclofenac sodium 20 MG/ML Topical SolutionSCDf9a0c654-5f77-430f-b921-295eb776cbcd11
1487074diclofenac sodium 2 % Topical SolutionSYf9a0c654-5f77-430f-b921-295eb776cbcd11
1487074diclofenac sodium 2 % Topical SolutionPSN3e15c3db-5245-76fb-e063-6394a90a814e2
1487074diclofenac sodium 20 MG/ML Topical SolutionSCD3e15c3db-5245-76fb-e063-6394a90a814e2
1487074diclofenac sodium 2 % Topical SolutionSY3e15c3db-5245-76fb-e063-6394a90a814e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-1369-8516721369081 BOTTLE, PUMP in 1 CARTON (51672-1369-8) / 112 g in 1 BOTTLE, PUMP2023-05-310000-00-00NoNoCurrent