FDA.reportPublic FDA data

Diclofenac Potassium

Product NDC
63629-4108
11-digit product format
636294108
Labeler code
63629
Product ID
63629-4108_37d9b7c1-4bf8-44ed-8d48-bd1ee6efd72c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075219
Marketing category
ANDA
Marketing start
1998-08-11
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
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 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
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-4108-12020-07-06C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-22020-07-06C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-32020-07-06C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-42020-07-06C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-52020-07-06C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-62020-07-06C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-72020-07-06C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-82020-07-06C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-12020-01-31C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-22020-01-31C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-32020-01-31C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-42020-01-31C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-52020-01-31C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-62020-01-31C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-72020-01-31C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only
63629-4108-82020-01-31C16284748780-19d75b9d0-3784-f424-e053-dadaa90a57ceDiclofenac Potassium Tablets, USP 50 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4108-1Diclofenac Potassium20 in 1 BOTTLETABLET, FILM COATED2015
63629-4108-2Diclofenac Potassium90 in 1 BOTTLETABLET, FILM COATED9015
63629-4108-3Diclofenac Potassium30 in 1 BOTTLETABLET, FILM COATED3015
63629-4108-4Diclofenac Potassium60 in 1 BOTTLETABLET, FILM COATED6015
63629-4108-5Diclofenac Potassium45 in 1 BOTTLETABLET, FILM COATED4515
63629-4108-6Diclofenac Potassium58 in 1 BOTTLETABLET, FILM COATED5815
63629-4108-7Diclofenac Potassium18 in 1 BOTTLETABLET, FILM COATED1815
63629-4108-8Diclofenac Potassium120 in 1 BOTTLETABLET, FILM COATED12015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4108-1EA - Each63629-4108b74cd462-e709-4af0-88b4-f4122227c13a12012-07-24
63629-4108-2EA - Each63629-410891d13089-91dc-488a-8b5d-e4903096703812012-07-24
63629-4108-3EA - Each63629-410899a05735-1416-4435-9d27-f546845648be12012-07-24
63629-4108-4EA - Each63629-4108d20831c2-314b-4ae0-b58b-b99942dd8c5512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC POTASSIUMACTIVE INGREDIENTL4D5UA6CB4DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EDICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP666DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4108DICLOFENAC POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]15Current NDC, Legacy NDC, 8 package rows20231004_717341fc-e067-0005-215c-053f6d12e0d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN717341fc-e067-0005-215c-053f6d12e0d115
855942diclofenac potassium 50 MG Oral TabletSCD717341fc-e067-0005-215c-053f6d12e0d115
855942Diclofenac K+ 50 MG Oral TabletSY717341fc-e067-0005-215c-053f6d12e0d115
855942Diclofenac Pot 50 MG Oral TabletSY717341fc-e067-0005-215c-053f6d12e0d115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4108-16362941080120 TABLET, FILM COATED in 1 BOTTLE (63629-4108-1) 2009-12-020000-00-00NoNoCurrent
63629-4108-26362941080290 TABLET, FILM COATED in 1 BOTTLE (63629-4108-2) 2010-04-200000-00-00NoNoCurrent
63629-4108-36362941080330 TABLET, FILM COATED in 1 BOTTLE (63629-4108-3) 2010-05-250000-00-00NoNoCurrent
63629-4108-46362941080460 TABLET, FILM COATED in 1 BOTTLE (63629-4108-4) 2011-01-060000-00-00NoNoCurrent
63629-4108-56362941080545 TABLET, FILM COATED in 1 BOTTLE (63629-4108-5) 2021-12-220000-00-00NoNoCurrent
63629-4108-66362941080658 TABLET, FILM COATED in 1 BOTTLE (63629-4108-6) 2021-12-220000-00-00NoNoCurrent
63629-4108-76362941080718 TABLET, FILM COATED in 1 BOTTLE (63629-4108-7) 2021-12-220000-00-00NoNoCurrent
63629-4108-863629410808120 TABLET, FILM COATED in 1 BOTTLE (63629-4108-8) 2021-12-220000-00-00NoNoCurrent