FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
16571-202
11-digit product format
165710202
Labeler code
16571
Product ID
16571-202_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
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 Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM50 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
16571-202-06Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE6020
16571-202-10Diclofenac Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE10020
16571-202-11Diclofenac Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-202-06EA - Each16571-202b9acc384-42e3-42b7-bfcf-79dabfcbd93612012-07-24
16571-202-10EA - Each16571-202e4788a5f-1b95-4dab-9429-679697971d1912012-07-24
16571-202-11EA - Each16571-2022a91f78e-a661-4a85-8d05-e90a98e6d5b812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diclofenac SodiumACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
hypromellosesINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
magnesium stearateINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
povidoneINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
talcINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
waterINACTIVE INGREDIENT059QF0KO0RDICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
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
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-202DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMA HOLDINGS, INC.]18Current NDC, Legacy NDC, 3 package rows20250418_3330ea92-fc9d-4541-b378-be399b0995d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNbfa8cb40-3528-4d41-ae77-444e521e30c03981
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNbfa8cb40-3528-4d41-ae77-444e521e30c03981
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDbfa8cb40-3528-4d41-ae77-444e521e30c03981
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDbfa8cb40-3528-4d41-ae77-444e521e30c03981
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
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN1e669fc2-69bf-4439-a336-a103e5b9cafe17
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN1e669fc2-69bf-4439-a336-a103e5b9cafe17
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD1e669fc2-69bf-4439-a336-a103e5b9cafe17
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD1e669fc2-69bf-4439-a336-a103e5b9cafe17
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN8825dc2c-3497-455f-b5e1-2aa6672919577
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNb3dbd981-453c-645f-e053-2a95a90aec3c7
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDb3dbd981-453c-645f-e053-2a95a90aec3c7
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD8825dc2c-3497-455f-b5e1-2aa6672919577
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN9eeb2aef-3eb1-4583-8180-d480deb3651c5
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN63c00b50-06d3-4659-81cf-be4516429e815
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD9eeb2aef-3eb1-4583-8180-d480deb3651c5
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD63c00b50-06d3-4659-81cf-be4516429e815
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN4e4112f6-0c9a-26d7-e054-00144ff8d46c4
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD4e4112f6-0c9a-26d7-e054-00144ff8d46c4
855664diclofenac sodium 25 MG Delayed Release Oral TabletPSN2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN4ee64a93-9965-47c8-be2c-14232df44b2b2
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN27f60ba8-a335-33b2-e054-00144ff8d46c2
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNaf480e78-ff65-4709-af26-c430aefb77d62
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 TabletSCD4ee64a93-9965-47c8-be2c-14232df44b2b2
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD27f60ba8-a335-33b2-e054-00144ff8d46c2
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDaf480e78-ff65-4709-af26-c430aefb77d62
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN1ea0a3ac-88ab-48c1-e054-00144ff8d46c1
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD1ea0a3ac-88ab-48c1-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-202-061657102020660 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-06) 2010-12-310000-00-00NoNoCurrent
16571-202-1016571020210100 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-10) 2010-12-310000-00-00NoNoCurrent
16571-202-11165710202111000 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-11) 2010-12-310000-00-00NoNoCurrent