FDA.reportPublic FDA data

DICLOFENAC POTASSIUM

Product NDC
13668-672
11-digit product format
136680672
Labeler code
13668
Product ID
13668-672_277a0748-cb35-429b-85fc-1f31c38c93db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICLOFENAC POTASSIUM
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA215891
Marketing category
ANDA
Marketing start
2025-01-22
Substance
DICLOFENAC POTASSIUM
Active strength
50 mg/1
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 POTASSIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC POTASSIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL4D5UA6CB4
Rxcui859063

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
13668-672-11DICLOFENAC POTASSIUM1 in 1 PACKETPOWDER, FOR SOLUTION18
13668-672-64DICLOFENAC POTASSIUM9 in 1 CARTONPOWDER, FOR SOLUTION98

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-672-11EA - Each13668-67209c22dca-2181-47cb-a95a-2936ecd191fc12025-05-14
13668-672-64EA - Each13668-672596db273-360a-4359-b938-c50b8eb2d6a312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-672DICLOFENAC POTASSIUM POWDER, FOR SOLUTION [TORRENT PHARMACEUTICALS LIMITED]7Current NDC, 2 package rows20250130_6a945fa8-6c62-40ba-ae97-b994cc90583e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859063diclofenac potassium 50 MG Powder for Oral SolutionPSN6a945fa8-6c62-40ba-ae97-b994cc90583e8
859063diclofenac potassium 50 MG Powder for Oral SolutionSCD6a945fa8-6c62-40ba-ae97-b994cc90583e8
859063Diclofenac K+ 50 MG Powder for Oral SolutionSY6a945fa8-6c62-40ba-ae97-b994cc90583e8
859063Diclofenac Pot 50 MG Powder for Oral SolutionSY6a945fa8-6c62-40ba-ae97-b994cc90583e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13668-672-11136680672111 in 1 PACKETHistorical
13668-672-64136680672649 PACKET in 1 CARTON (13668-672-64) / 1 POWDER, FOR SOLUTION in 1 PACKET (13668-672-11) 9 packet2025-01-22NoNoCurrent