FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
16571-203
11-digit product format
165710203
Labeler code
16571
Product ID
16571-203_504b1904-033c-4fd8-92c9-41e31154f808
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA090066
Marketing category
ANDA
Marketing start
2010-12-31
Substance
DICLOFENAC SODIUM
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 Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855664, 855906, 855926

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
16571-203-03Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3020
16571-203-10Diclofenac Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-203-10EA - Each16571-203a223521b-bd27-4317-8a95-f5a7e1e51a4212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diclofenac SodiumACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
DiclofenacACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
POVIDONESINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RDICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-203DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMA HOLDINGS, INC.]18Current NDC, Legacy NDC, 2 package rows20250418_3330ea92-fc9d-4541-b378-be399b0995d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855664diclofenac sodium 25 MG Delayed Release Oral TabletPSN4e97c685-628a-4b83-ba9e-2d3caf65542b102
855664diclofenac sodium 25 MG Delayed Release Oral TabletSCD4e97c685-628a-4b83-ba9e-2d3caf65542b102
855664diclofenac sodium 25 MG Delayed Release Oral TabletPSN3330ea92-fc9d-4541-b378-be399b0995d320
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN3330ea92-fc9d-4541-b378-be399b0995d320
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN3330ea92-fc9d-4541-b378-be399b0995d320
855664diclofenac sodium 25 MG Delayed Release Oral TabletSCD3330ea92-fc9d-4541-b378-be399b0995d320
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD3330ea92-fc9d-4541-b378-be399b0995d320
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD3330ea92-fc9d-4541-b378-be399b0995d320
855664diclofenac sodium 25 MG Delayed Release Oral TabletPSN2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82
855664diclofenac sodium 25 MG Delayed Release Oral TabletSCD2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-203-031657102030330 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-203-03) 2024-07-22NoNoHistorical
16571-203-1016571020310100 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-203-10) 2010-12-310000-00-00NoNoCurrent