Diclofenac sodium

Product NDC
51672-1363
11-digit product format
516721363
Labeler code
51672
Product ID
51672-1363_38ef9dc7-662f-056c-e063-6394a90a47e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA206298
Marketing category
ANDA
Marketing start
2016-04-28
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
51672-1363-3Diclofenac sodium1 in 1 CARTONGEL111
51672-1363-3Diclofenac sodium50 g in 1 TUBEGEL5011
51672-1363-7Diclofenac sodium100 g in 1 TUBEGEL10011
51672-1363-7Diclofenac sodium1 in 1 CARTONGEL111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1363DICLOFENAC SODIUM GEL [TARO PHARMACEUTICALS U.S.A., INC.]10Current NDC, Legacy NDC, 4 package rows20250124_aa1e1ed3-0444-4bf5-a0ee-5d21a7fca391.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855642diclofenac sodium 3 % Topical GelPSNaa1e1ed3-0444-4bf5-a0ee-5d21a7fca39111
855642diclofenac sodium 0.03 MG/MG Topical GelSCDaa1e1ed3-0444-4bf5-a0ee-5d21a7fca39111
855642diclofenac sodium 3 % Topical GelSYaa1e1ed3-0444-4bf5-a0ee-5d21a7fca39111
855642diclofenac sodium 3 % Topical GelPSN81bfeada-6589-4528-bea5-059ab0fabb434
855642diclofenac sodium 0.03 MG/MG Topical GelSCD81bfeada-6589-4528-bea5-059ab0fabb434
855642diclofenac sodium 3 % Topical GelSY81bfeada-6589-4528-bea5-059ab0fabb434
855642diclofenac sodium 3 % Topical GelPSNf1892aae-7264-3b4c-e053-2995a90a88023
855642diclofenac sodium 0.03 MG/MG Topical GelSCDf1892aae-7264-3b4c-e053-2995a90a88023
855642diclofenac sodium 3 % Topical GelSYf1892aae-7264-3b4c-e053-2995a90a88023
855642diclofenac sodium 3 % Topical GelPSN946b3799-2d56-12a5-e053-2a95a90aeba02
855642diclofenac sodium 3 % Topical GelPSNb98d921a-2ee7-4770-ac21-d845b2dcc11c2
855642diclofenac sodium 0.03 MG/MG Topical GelSCD946b3799-2d56-12a5-e053-2a95a90aeba02
855642diclofenac sodium 0.03 MG/MG Topical GelSCDb98d921a-2ee7-4770-ac21-d845b2dcc11c2
855642diclofenac sodium 3 % Topical GelSY946b3799-2d56-12a5-e053-2a95a90aeba02
855642diclofenac sodium 3 % Topical GelSYb98d921a-2ee7-4770-ac21-d845b2dcc11c2
855642diclofenac sodium 3 % Topical GelPSN22f4b8aa-902f-a860-e063-6394a90ada261
855642diclofenac sodium 3 % Topical GelPSN14a85a88-c941-94ea-e063-6394a90a4e141
855642diclofenac sodium 3 % Topical GelPSNe6f7a2b0-7d1b-4cf0-8d8d-47b762164f071
855642diclofenac sodium 3 % Topical GelPSNd4b81a74-6926-4715-bf90-aec026cff2b41
855642diclofenac sodium 0.03 MG/MG Topical GelSCD14a85a88-c941-94ea-e063-6394a90a4e141
855642diclofenac sodium 0.03 MG/MG Topical GelSCDe6f7a2b0-7d1b-4cf0-8d8d-47b762164f071
855642diclofenac sodium 0.03 MG/MG Topical GelSCDd4b81a74-6926-4715-bf90-aec026cff2b41
855642diclofenac sodium 0.03 MG/MG Topical GelSCD22f4b8aa-902f-a860-e063-6394a90ada261
855642diclofenac sodium 3 % Topical GelSYd4b81a74-6926-4715-bf90-aec026cff2b41
855642diclofenac sodium 3 % Topical GelSYe6f7a2b0-7d1b-4cf0-8d8d-47b762164f071
855642diclofenac sodium 3 % Topical GelSY14a85a88-c941-94ea-e063-6394a90a4e141
855642diclofenac sodium 3 % Topical GelSY22f4b8aa-902f-a860-e063-6394a90ada261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1363-3516721363031 TUBE in 1 CARTON (51672-1363-3) / 50 g in 1 TUBE1 tube2016-04-280000-00-00NoNoCurrent
51672-1363-7516721363071 TUBE in 1 CARTON (51672-1363-7) / 100 g in 1 TUBE1 tube2016-04-280000-00-00NoNoCurrent