Diclofenac Potassium

Product NDC
72888-086
11-digit product format
728880086
Labeler code
72888
Product ID
72888-086_473c6621-0a69-12fd-e063-6294a90a1fb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA075229
Marketing category
ANDA
Marketing start
2021-03-16
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075229-001DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM50MGTABLET / ORALABRS1998-11-20
A075229-002DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075229-001AB
A075229-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALABRS1998-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALABRS1998-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALABRS1998-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB1998-11-2087673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075229-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075229-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075229-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075229-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075229-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075229-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075229-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075229-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075229-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075229-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075229-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075229-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075229-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075229-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075229-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075229-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075229-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075229-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075229-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075229-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075229-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075229-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075229-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075229-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075229-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075229-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075229-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075229-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075229-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075229-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075229-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075229-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075229-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075229-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075229-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075229-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075229-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075229-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075229-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075229-001AB187673890dc5c…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L4D5UA6CB4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855942Internal RxNorm lookup
857702Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
82218d5c-1625-471a-aabe-f43338e5176bAvailable on FDA.report

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
72888-086-00Diclofenac Potassium1000 in 1 BOTTLETABLET, COATED10006
72888-086-01Diclofenac Potassium100 in 1 BOTTLETABLET, COATED1006
72888-086-30Diclofenac Potassium30 in 1 BOTTLETABLET, COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-086-30EA - Each72888-086b45d0104-be77-4c5a-b681-a96a237e094112022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-086DICLOFENAC POTASSIUM TABLET, COATED [ADVAGEN PHARMA LTD]5Current NDC, Legacy NDC, 3 package rows20220205_82218d5c-1625-471a-aabe-f43338e5176b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac PotassiumDICLOFENAC POTASSIUMNuCare Pharmaceuticals,Inc.d61cbb27-737d-948c-e053-2a95a90adaca2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
Diclofenac PotassiumDICLOFENAC POTASSIUMBryant Ranch Prepack86461915-9bc1-43d4-8d92-6eef3e56bd902026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
Diclofenac PotassiumDICLOFENAC POTASSIUMNorthwind Health Company, LLCf2b6a4dd-e4e2-4acc-e053-2995a90aebf22026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
Diclofenac PotassiumDICLOFENAC POTASSIUMAdvagen Pharma Ltd82218d5c-1625-471a-aabe-f43338e5176b2025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
ndc (product): 72888-086
Diclofenac PotassiumDICLOFENAC POTASSIUMTrifluent Pharma LLC8fdb1036-c0d8-4288-ac37-6512b05672ef2025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
Diclofenac PotassiumDICLOFENAC POTASSIUMINA Pharmaceutics Inc5ecd99fe-cb74-4a65-9636-2aefd2416ece2025-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
Diclofenac PotassiumDICLOFENAC POTASSIUMCoupler LLC2eead069-f954-abb2-e063-6394a90a14ff2025-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
Diclofenac PotassiumDICLOFENAC POTASSIUMA-S Medication Solutions112e7c94-23c8-451e-ae71-eb89a6eb2cb22023-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
Diclofenac PotassiumDICLOFENAC POTASSIUMProficient Rx LP94586867-c75b-4d60-be1d-03a9e4b7cd102023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857702diclofenac potassium 25 MG Oral TabletPSN82218d5c-1625-471a-aabe-f43338e5176b6
855942diclofenac potassium 50 MG Oral TabletPSN82218d5c-1625-471a-aabe-f43338e5176b6
857702diclofenac potassium 25 MG Oral TabletSCD82218d5c-1625-471a-aabe-f43338e5176b6
855942diclofenac potassium 50 MG Oral TabletSCD82218d5c-1625-471a-aabe-f43338e5176b6
857702Diclofenac K+ 25 MG Oral TabletSY82218d5c-1625-471a-aabe-f43338e5176b6
855942Diclofenac K+ 50 MG Oral TabletSY82218d5c-1625-471a-aabe-f43338e5176b6
857702Diclofenac Pot 25 MG Oral TabletSY82218d5c-1625-471a-aabe-f43338e5176b6
855942Diclofenac Pot 50 MG Oral TabletSY82218d5c-1625-471a-aabe-f43338e5176b6
857702diclofenac potassium 25 MG Oral TabletPSN1d8b43e2-114d-8360-e063-6394a90ac2951
857702diclofenac potassium 25 MG Oral TabletSCD1d8b43e2-114d-8360-e063-6394a90ac2951
857702Diclofenac K+ 25 MG Oral TabletSY1d8b43e2-114d-8360-e063-6394a90ac2951
857702Diclofenac Pot 25 MG Oral TabletSY1d8b43e2-114d-8360-e063-6394a90ac2951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-086-00728880086001000 TABLET, COATED in 1 BOTTLE (72888-086-00) 2021-03-160000-00-00NoNoCurrent
72888-086-0172888008601100 TABLET, COATED in 1 BOTTLE (72888-086-01) 2021-03-160000-00-00NoNoCurrent
72888-086-307288800863030 TABLET, COATED in 1 BOTTLE (72888-086-30) 2021-03-160000-00-00NoNoCurrent