FDA.reportPublic FDA data

Diclofenac sodium

Product NDC
0536-1294
11-digit product format
005361294
Labeler code
0536
Product ID
0536-1294_8b734e52-fc53-489b-97a3-bea23f008d40
Type
HUMAN OTC DRUG
Nonproprietary name
Diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Rugby Laboratories
Application
ANDA208077
Marketing category
ANDA
Marketing start
2020-09-14
Substance
DICLOFENAC SODIUM
Active strength
10 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855633

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
0536-1294-31Diclofenac sodium1 in 1 CARTONGEL115
0536-1294-31Diclofenac sodium150 g in 1 TUBEGEL15015
0536-1294-34Diclofenac sodium1 in 1 CARTONGEL115
0536-1294-34Diclofenac sodium50 g in 1 TUBEGEL5015
0536-1294-97Diclofenac sodium100 g in 1 TUBEGEL10015
0536-1294-97Diclofenac sodium1 in 1 CARTONGEL115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1294-31GM - Gram0536-1294669d1824-0510-4fcc-b606-79de97c4e10d12021-01-08
0536-1294-34GM - Gram0536-12945c6ecb32-5691-493d-8069-86a73d2d774a12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1294DICLOFENAC SODIUM GEL [RUGBY LABORATORIES, INC.]11Current NDC, Legacy NDC, 6 package rows20241027_95f3c70c-eded-4d24-b9b0-cfa0b7902d6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN95f3c70c-eded-4d24-b9b0-cfa0b7902d6e15
855633diclofenac sodium 0.01 MG/MG Topical GelSCD95f3c70c-eded-4d24-b9b0-cfa0b7902d6e15
855633diclofenac sodium 1 % Topical GelSY95f3c70c-eded-4d24-b9b0-cfa0b7902d6e15
855633diclofenac sodium 1 % Topical GelPSNac631742-119f-408a-8b36-b041bab743e21
855633diclofenac sodium 0.01 MG/MG Topical GelSCDac631742-119f-408a-8b36-b041bab743e21
855633diclofenac sodium 1 % Topical GelSYac631742-119f-408a-8b36-b041bab743e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1294-31005361294311 TUBE in 1 CARTON (0536-1294-31) / 150 g in 1 TUBE1 tube2020-09-142027-10-28NoNoCurrent
0536-1294-34005361294341 TUBE in 1 CARTON (0536-1294-34) / 50 g in 1 TUBE1 tube2020-09-142023-06-28NoNoCurrent
0536-1294-97005361294971 TUBE in 1 CARTON (0536-1294-97) / 100 g in 1 TUBE1 tube2020-09-142023-06-28NoNoCurrent