FDA.reportPublic FDA data

Diclofenac Potassium

Product NDC
70710-1832
11-digit product format
707101832
Labeler code
70710
Product ID
70710-1832_47dd2b04-1417-2e67-e063-6294a90ae24b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Potassium Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA215750
Marketing category
ANDA
Marketing start
2022-05-12
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
Rxcui855942

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
70710-1832-0Diclofenac Potassium1000 in 1 BOTTLETABLET, FILM COATED10008
70710-1832-1Diclofenac Potassium100 in 1 BOTTLETABLET, FILM COATED1008
70710-1832-5Diclofenac Potassium500 in 1 BOTTLETABLET, FILM COATED5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1832-1EA - Each70710-1832028b95fb-84ce-4ac1-8014-a462ad75c50212022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1832DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM TABLETS) TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7Current NDC, Legacy NDC, 3 package rows20241225_1aa3d8d6-dd1c-46c7-96f9-2b5c9d72764a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN94898228-c595-4fd6-acc2-13dbdbde9c0e104
855942diclofenac potassium 50 MG Oral TabletSCD94898228-c595-4fd6-acc2-13dbdbde9c0e104
855942Diclofenac K+ 50 MG Oral TabletSY94898228-c595-4fd6-acc2-13dbdbde9c0e104
855942Diclofenac Pot 50 MG Oral TabletSY94898228-c595-4fd6-acc2-13dbdbde9c0e104
855942diclofenac potassium 50 MG Oral TabletPSN1aa3d8d6-dd1c-46c7-96f9-2b5c9d72764a8
855942diclofenac potassium 50 MG Oral TabletSCD1aa3d8d6-dd1c-46c7-96f9-2b5c9d72764a8
855942Diclofenac K+ 50 MG Oral TabletSY1aa3d8d6-dd1c-46c7-96f9-2b5c9d72764a8
855942Diclofenac Pot 50 MG Oral TabletSY1aa3d8d6-dd1c-46c7-96f9-2b5c9d72764a8
855942diclofenac potassium 50 MG Oral TabletPSNffc41543-a353-cade-e053-6294a90a99fb3
855942diclofenac potassium 50 MG Oral TabletSCDffc41543-a353-cade-e053-6294a90a99fb3
855942Diclofenac K+ 50 MG Oral TabletSYffc41543-a353-cade-e053-6294a90a99fb3
855942Diclofenac Pot 50 MG Oral TabletSYffc41543-a353-cade-e053-6294a90a99fb3
855942diclofenac potassium 50 MG Oral TabletPSN5d37fc5a-7a2f-432e-b4e9-e00c246ce33c1
855942diclofenac potassium 50 MG Oral TabletSCD5d37fc5a-7a2f-432e-b4e9-e00c246ce33c1
855942Diclofenac K+ 50 MG Oral TabletSY5d37fc5a-7a2f-432e-b4e9-e00c246ce33c1
855942Diclofenac Pot 50 MG Oral TabletSY5d37fc5a-7a2f-432e-b4e9-e00c246ce33c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70710-1832-0707101832001000 TABLET, FILM COATED in 1 BOTTLE (70710-1832-0) 2022-05-120000-00-00NoNoCurrent
70710-1832-170710183201100 TABLET, FILM COATED in 1 BOTTLE (70710-1832-1) 2022-05-120000-00-00NoNoCurrent
70710-1832-570710183205500 TABLET, FILM COATED in 1 BOTTLE (70710-1832-5) 2022-05-12NoNoCurrent