FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
46708-581
11-digit product format
467080581
Labeler code
46708
Product ID
46708-581_cc529794-6914-479b-8f58-86f5746c2a89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium Topical
Dosage form
GEL
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA212351
Marketing category
ANDA
Marketing start
2025-03-04
Substance
DICLOFENAC SODIUM
Active strength
30 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 SODIUM30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855642

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-581-31Diclofenac Sodium1 in 1 CARTONGEL11
46708-581-31Diclofenac Sodium100 g in 1 TUBEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-581DICLOFENAC SODIUM (DICLOFENAC SODIUM TOPICAL) GEL [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20250306_11adfe0f-e774-4ccf-8a57-0c7d47aeb0dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855642diclofenac sodium 3 % Topical GelPSN11adfe0f-e774-4ccf-8a57-0c7d47aeb0dd1
855642diclofenac sodium 0.03 MG/MG Topical GelSCD11adfe0f-e774-4ccf-8a57-0c7d47aeb0dd1
855642diclofenac sodium 3 % Topical GelSY11adfe0f-e774-4ccf-8a57-0c7d47aeb0dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-581-31467080581311 TUBE in 1 CARTON (46708-581-31) / 100 g in 1 TUBE1 tube2025-03-04NoNoCurrent