FDA.reportPublic FDA data

DICLOFENAC SODIUM

Product NDC
21922-033
11-digit product format
219220033
Labeler code
21922
Product ID
21922-033_28dafbef-5a91-4435-b48d-00137ea268b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICLOFENAC
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA217646
Marketing category
ANDA
Marketing start
2025-04-14
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
21922-033-16DICLOFENAC SODIUM1 in 1 CARTONSOLUTION14
21922-033-16DICLOFENAC SODIUM112 g in 1 BOTTLE, PUMPSOLUTION1124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-033-16GM - Gram21922-0338fccc420-8f2a-4014-9941-0eba7c8e7a8f12025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-033DICLOFENAC SODIUM (DICLOFENAC) SOLUTION [ENCUBE ETHICALS PRIVATE LIMITED]3Current NDC, 2 package rows20250419_e7304b3e-530a-4519-aed0-bed4512d8925.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1487074diclofenac sodium 2 % Topical SolutionPSNe7304b3e-530a-4519-aed0-bed4512d89254
1487074diclofenac sodium 20 MG/ML Topical SolutionSCDe7304b3e-530a-4519-aed0-bed4512d89254
1487074diclofenac sodium 2 % Topical SolutionSYe7304b3e-530a-4519-aed0-bed4512d89254

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
21922-033-16219220033161 BOTTLE, PUMP in 1 CARTON (21922-033-16) / 112 g in 1 BOTTLE, PUMP2025-04-14NoNoCurrent