FDA.reportPublic FDA data

Diclofenac sodium

Product NDC
63941-812
11-digit product format
639410812
Labeler code
63941
Product ID
63941-812_0637e9d2-8b6e-4b8b-9a3e-0ab22036a19f
Type
HUMAN OTC DRUG
Nonproprietary name
Diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Best Choice (Valu Merchandisers Company)
Application
ANDA208077
Marketing category
ANDA
Marketing start
2020-07-30
Marketing end
2026-12-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac sodium

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
63941-812-53Diclofenac sodium100 g in 1 TUBEGEL1004
63941-812-53Diclofenac sodium1 in 1 CARTONGEL14
63941-812-76Diclofenac sodium50 g in 1 TUBEGEL504
63941-812-76Diclofenac sodium1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-812DICLOFENAC SODIUM GEL [BEST CHOICE (VALU MERCHANDISERS COMPANY)]3Current NDC, Legacy NDC, 4 package rows20221122_4ea809a9-387a-4193-a176-d8b22eaa55e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN4ea809a9-387a-4193-a176-d8b22eaa55e64
855633diclofenac sodium 0.01 MG/MG Topical GelSCD4ea809a9-387a-4193-a176-d8b22eaa55e64
855633diclofenac sodium 1 % Topical GelSY4ea809a9-387a-4193-a176-d8b22eaa55e64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-812-53639410812531 TUBE in 1 CARTON (63941-812-53) / 100 g in 1 TUBE1 tube2020-07-302026-12-30NoNoCurrent
63941-812-76639410812761 TUBE in 1 CARTON (63941-812-76) / 50 g in 1 TUBE1 tube2020-07-302026-12-30NoNoCurrent