Diclofenac Potassium

Product NDC
49884-905
11-digit product format
498840905
Labeler code
49884
Product ID
49884-905_883f5ee2-2d94-4fd7-9838-d4b572c9e0c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Potassium
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA202964
Marketing category
ANDA
Marketing start
2023-01-03
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49884-90549884-905-24DDiscontinued by firm2026-08-11
excluded packagepackage49884-90549884-905-52DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0549884-905-52d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549884-905-24d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2649884-905-52f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649884-905-24f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3149884-905-522ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149884-905-242ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2849884-905-52a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849884-905-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2149884-905-52cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149884-905-24cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1049884-905-52cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049884-905-24cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3149884-905-52302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3149884-905-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2049884-905-52ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2049884-905-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1049884-905-520efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1049884-905-240efc9e666f02…f202fb6c5f17…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202964-001DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202964-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-023f01610625f2…
2019-09-15 20:21 UTC2019-09A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202964-001DICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALAB2016-05-02cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202964-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202964-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202964-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202964-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202964-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202964-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202964-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202964-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202964-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202964-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202964-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202964-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202964-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202964-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202964-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202964-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202964-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202964-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202964-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202964-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202964-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202964-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202964-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202964-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202964-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202964-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202964-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202964-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202964-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202964-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202964-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202964-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202964-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202964-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202964-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202964-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202964-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202964-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202964-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202964-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Potassium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC POTASSIUM50 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d45648f-cbea-41a4-8e3e-007b7bb7912cAvailable 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-905-24Diclofenac Potassium3 in 1 CARTONPOWDER, FOR SOLUTION326
49884-905-52Diclofenac Potassium1 in 1 PACKETPOWDER, FOR SOLUTION126
49884-905-64Diclofenac Potassium9 in 1 CARTONPOWDER, FOR SOLUTION926

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-905-52EA - Each49884-9055a95e4ba-452f-4782-a729-4bc4021916cd12023-02-06
49884-905-64EA - Each49884-9057ab72533-968e-4bea-8658-3e140592008512023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-905DICLOFENAC POTASSIUM POWDER, FOR SOLUTION [ENDO USA, INC.]26Current NDC, Legacy NDC, 3 package rows20241212_2d45648f-cbea-41a4-8e3e-007b7bb7912c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac PotassiumDICLOFENAC POTASSIUMPar Health USA, LLC2d45648f-cbea-41a4-8e3e-007b7bb7912c2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202964
application number: ANDA202964
ndc (product): 49884-905

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859063diclofenac potassium 50 MG Powder for Oral SolutionPSN2d45648f-cbea-41a4-8e3e-007b7bb7912c26
859063diclofenac potassium 50 MG Powder for Oral SolutionSCD2d45648f-cbea-41a4-8e3e-007b7bb7912c26
859063Diclofenac K+ 50 MG Powder for Oral SolutionSY2d45648f-cbea-41a4-8e3e-007b7bb7912c26
859063Diclofenac Pot 50 MG Powder for Oral SolutionSY2d45648f-cbea-41a4-8e3e-007b7bb7912c26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-905-24498840905243 POWDER, FOR SOLUTION in 1 CARTON (49884-905-24) 2023-01-030000-00-00NoNoCurrent
49884-905-52498840905521 POWDER, FOR SOLUTION in 1 PACKET (49884-905-52) 2023-01-030000-00-00NoNoCurrent
49884-905-64498840905649 POWDER, FOR SOLUTION in 1 CARTON (49884-905-64) 2023-01-030000-00-00NoNoCurrent