FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
0472-1783
11-digit product format
004721783
Labeler code
0472
Product ID
0472-1783_6b4784a2-31ca-485a-9bff-6c322c0cb902
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA206493
Marketing category
ANDA
Marketing start
2016-05-19
Marketing end
2027-02-28
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0472-1783-10Diclofenac Sodium1 in 1 CARTONGEL125
0472-1783-10Diclofenac Sodium100 g in 1 TUBEGEL10025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-1783-10GM - Gram0472-1783804fa46b-5d5f-4838-9f3c-ea565216b67112016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-1783DICLOFENAC SODIUM GEL [ACTAVIS PHARMA, INC.]24Current NDC, Legacy NDC, 2 package rows20250215_74169b2d-ac56-4757-86c4-cdcfcd5f4eb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855642diclofenac sodium 3 % Topical GelPSN74169b2d-ac56-4757-86c4-cdcfcd5f4eb525
855642diclofenac sodium 0.03 MG/MG Topical GelSCD74169b2d-ac56-4757-86c4-cdcfcd5f4eb525
855642diclofenac sodium 3 % Topical GelSY74169b2d-ac56-4757-86c4-cdcfcd5f4eb525
855642diclofenac sodium 3 % Topical GelPSN7110c678-15a5-4d12-b589-7e233a07beea2
855642diclofenac sodium 0.03 MG/MG Topical GelSCD7110c678-15a5-4d12-b589-7e233a07beea2
855642diclofenac sodium 3 % Topical GelSY7110c678-15a5-4d12-b589-7e233a07beea2
855642diclofenac sodium 3 % Topical GelPSNb162d65d-b105-4a68-90bb-316b9686267b1
855642diclofenac sodium 3 % Topical GelPSNb41335b6-859f-4568-84d2-0d0408415a4e1
855642diclofenac sodium 0.03 MG/MG Topical GelSCDb162d65d-b105-4a68-90bb-316b9686267b1
855642diclofenac sodium 0.03 MG/MG Topical GelSCDb41335b6-859f-4568-84d2-0d0408415a4e1
855642diclofenac sodium 3 % Topical GelSYb162d65d-b105-4a68-90bb-316b9686267b1
855642diclofenac sodium 3 % Topical GelSYb41335b6-859f-4568-84d2-0d0408415a4e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-1783-10004721783101 TUBE in 1 CARTON (0472-1783-10) / 100 g in 1 TUBE1 tube2016-05-192027-02-28NoNoCurrent