FDA.reportPublic FDA data

diclofenac sodium

Product NDC
45802-111
11-digit product format
458020111
Labeler code
45802
Product ID
45802-111_eeb0495b-abe8-4efe-bc64-17a7278dbe29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA210893
Marketing category
ANDA
Marketing start
2018-11-27
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
45802-111-01diclofenac sodium1 in 1 CARTONGEL18
45802-111-01diclofenac sodium100 g in 1 TUBEGEL1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-111-01GM - Gram45802-111fcc10a08-1b2c-4e7c-940b-c94a187b90b812018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-111DICLOFENAC SODIUM GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD]8Current NDC, Legacy NDC, 2 package rows20240731_3f0f3514-c3f7-4dab-8e5f-ddf89adbe3b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855642diclofenac sodium 3 % Topical GelPSN16853c78-493a-4b8b-87b9-97dc927e1c8e109
855642diclofenac sodium 0.03 MG/MG Topical GelSCD16853c78-493a-4b8b-87b9-97dc927e1c8e109
855642diclofenac sodium 3 % Topical GelSY16853c78-493a-4b8b-87b9-97dc927e1c8e109
855642diclofenac sodium 3 % Topical GelPSNbf372e32-0902-447f-9673-00a3fcf0064c102
855642diclofenac sodium 0.03 MG/MG Topical GelSCDbf372e32-0902-447f-9673-00a3fcf0064c102
855642diclofenac sodium 3 % Topical GelSYbf372e32-0902-447f-9673-00a3fcf0064c102
855642diclofenac sodium 3 % Topical GelPSN6aab6c1f-9b02-4101-b7c8-ab7a5570432012
855642diclofenac sodium 0.03 MG/MG Topical GelSCD6aab6c1f-9b02-4101-b7c8-ab7a5570432012
855642diclofenac sodium 3 % Topical GelSY6aab6c1f-9b02-4101-b7c8-ab7a5570432012
855642diclofenac sodium 3 % Topical GelPSN3f0f3514-c3f7-4dab-8e5f-ddf89adbe3b88
855642diclofenac sodium 0.03 MG/MG Topical GelSCD3f0f3514-c3f7-4dab-8e5f-ddf89adbe3b88
855642diclofenac sodium 3 % Topical GelSY3f0f3514-c3f7-4dab-8e5f-ddf89adbe3b88
855642diclofenac sodium 3 % Topical GelPSN8721da56-0f8a-5903-e053-2991aa0a61b54
855642diclofenac sodium 0.03 MG/MG Topical GelSCD8721da56-0f8a-5903-e053-2991aa0a61b54
855642diclofenac sodium 3 % Topical GelSY8721da56-0f8a-5903-e053-2991aa0a61b54
855642diclofenac sodium 3 % Topical GelPSN14bb9851-5b86-d234-e063-6394a90acf271
855642diclofenac sodium 3 % Topical GelPSN67e384c6-8476-4aad-b967-241335538d561
855642diclofenac sodium 0.03 MG/MG Topical GelSCD67e384c6-8476-4aad-b967-241335538d561
855642diclofenac sodium 0.03 MG/MG Topical GelSCD14bb9851-5b86-d234-e063-6394a90acf271
855642diclofenac sodium 3 % Topical GelSY67e384c6-8476-4aad-b967-241335538d561
855642diclofenac sodium 3 % Topical GelSY14bb9851-5b86-d234-e063-6394a90acf271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-111-01458020111011 TUBE in 1 CARTON (45802-111-01) / 100 g in 1 TUBE1 tube2018-11-270000-00-00NoNoCurrent