FDA.reportPublic FDA data

Diclofenac potassium

Product NDC
0480-9435
11-digit product format
004809435
Labeler code
0480
Product ID
0480-9435_40461510-7592-d588-e063-6394a90a8b9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TEVA PHARMACEUTICALS, INC.
Application
ANDA204648
Marketing category
ANDA
Marketing start
2022-03-24
Substance
DICLOFENAC POTASSIUM
Active strength
25 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC POTASSIUM25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL4D5UA6CB4
Rxcui858342

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-9435-89Diclofenac potassium120 in 1 BOTTLECAPSULE, LIQUID FILLED1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-9435-89EA - Each0480-9435ad3b6ba6-888c-4e06-82f8-5382585fb68a12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-9435DICLOFENAC POTASSIUM CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 1 package rows20220324_d9685883-9d0b-81da-e053-2a95a90ab8d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858342diclofenac potassium 25 MG Oral CapsulePSNd9685883-9d0b-81da-e053-2a95a90ab8d82
858342diclofenac 25 MG Oral CapsuleSCDd9685883-9d0b-81da-e053-2a95a90ab8d82
858342diclofenac 25 MG (equivalent to diclofenac potassium 28.3 MG) Oral CapsuleSYd9685883-9d0b-81da-e053-2a95a90ab8d82
858342diclofenac potassium 25 MG Oral CapsulePSN8c54e404-2dbd-49cd-8235-b2a708bae5631
858342diclofenac 25 MG Oral CapsuleSCD8c54e404-2dbd-49cd-8235-b2a708bae5631
858342diclofenac 25 MG (equivalent to diclofenac potassium 28.3 MG) Oral CapsuleSY8c54e404-2dbd-49cd-8235-b2a708bae5631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0480-9435-8900480943589120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-9435-89) 2022-03-240000-00-00NoNoCurrent