DICLOFENAC POTASSIUM

Product NDC
87127-802
Requested package NDC
87127-802-60
11-digit product format
871270802
Labeler code
87127
Product ID
87127-802_40a794e1-a2dc-e0ef-e063-6394a90a86df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium, film coated
Dosage form
TABLET
Route
ORAL
Labeler
Happy Robin, LLC
Application
ANDA215787
Marketing category
ANDA
Marketing start
2025-09-24
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
A215787-001DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-15
A215787-002DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215787-001AB
A215787-002AB

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 · 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 UTC2026-02A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-098072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-156a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-151c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-15ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215787-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2023-11-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-15053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215787-001DICLOFENAC POTASSIUM50MGTABLET / ORALAB2023-03-15a50c72e98297…

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 UTC2026-02A215787-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215787-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215787-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215787-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215787-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215787-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215787-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215787-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215787-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215787-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215787-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215787-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215787-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215787-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215787-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215787-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215787-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215787-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215787-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215787-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215787-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215787-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215787-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215787-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215787-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215787-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215787-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215787-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215787-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215787-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215787-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215787-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215787-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215787-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215787-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215787-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215787-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215787-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A215787-001AB1053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215787-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDAmerisyn LLCb0931350-28a9-4f00-9254-1d72e31f04c32026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDVICI Pharmaceuticals, Inc544a869e-60ef-627b-e063-6294a90a3fd82026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787
Diclofenac PotassiumDICLOFENAC POTASSIUMPHOENIX RX LLC43448b74-6c02-a581-e063-6394a90a63ba2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787
Diclofenac PotassiumDICLOFENAC POTASSIUMSOLA Pharmaceuticals, LLCe770efc8-bbad-4103-98e4-e31019a540f52026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDINA Pharmaceutics Inc,6c703075-b9a3-42de-87f6-fd1e1ef4b2e32025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787
Diclofenac PotassiumDICLOFENAC POTASSIUMSOLA Pharmaceuticals, LLC26bf3a4a-42c6-cb59-e063-6394a90abd8b2025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787
Diclofenac PotassiumDICLOFENAC POTASSIUMDoc Rx6394ab5f-b3ff-4397-97eb-ff92485c5ec02025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787
Diclofenac PotassiumDICLOFENAC POTASSIUMPhoenix RX LLC3fd418ac-49f6-d520-e063-6394a90afbd82025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDGolden State Medical Supply, Inc.26d0ed73-b7a6-cbd8-e063-6394a90a9a312025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDHappy Robin, LLC3f91023f-9db9-88ba-e063-6394a90abd442025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787
ndc (package): 87127-802-60
ndc (product): 87127-802
ndc11 (package): 87127080260
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDAmici Pharma, Incc4ce1497-9cb1-4632-b1a2-4f61043c018d2025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787
Diclofenac PotassiumDICLOFENAC POTASSIUMAdvanced Rx of Tennessee, LLC295d167c-eb56-8e14-e063-6394a90ad3252024-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787
Diclofenac PotassiumDICLOFENAC POTASSIUMAdvanced Rx of Tennessee, LLC295d5dab-8890-d76e-e063-6394a90ad4022024-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDCintex Services, LLC0cdea9d3-fada-b00e-e063-6394a90ad5d92024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDHavix Group Inc d-b-a Aavis Pharmaceuticals30ab7b30-cc90-4b84-8caf-21058f1d37fa2023-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215787
application number: ANDA215787

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
3f91023f-9db9-88ba-e063-6394a90abd44Available 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
87127-802-60DICLOFENAC POTASSIUM60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
87127-802-60EA - Each87127-8027329f003-284d-4511-876e-403583df357b12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857702diclofenac potassium 25 MG Oral TabletPSN3f91023f-9db9-88ba-e063-6394a90abd443
857702diclofenac potassium 25 MG Oral TabletSCD3f91023f-9db9-88ba-e063-6394a90abd443
857702Diclofenac K+ 25 MG Oral TabletSY3f91023f-9db9-88ba-e063-6394a90abd443
857702Diclofenac Pot 25 MG Oral TabletSY3f91023f-9db9-88ba-e063-6394a90abd443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87127-802-608712708026060 TABLET in 1 BOTTLE (87127-802-60) 60 tablet2025-09-24NoNoCurrent