DICLOFENAC POTASSIUM

Product NDC
71337-046
11-digit product format
713370046
Labeler code
71337
Product ID
71337-046_2a1e049f-58f9-40e8-b7a6-bcd19ef51f75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium, film coated
Dosage form
TABLET
Route
ORAL
Labeler
Havix Group Inc d-b-a Aavis Pharmaceuticals
Application
ANDA215787
Marketing category
ANDA
Marketing start
2023-06-25
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

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…

Additional Listing Data#

Finished product
Yes
Brand name base
DICLOFENAC POTASSIUM
Listing expiration
2026-12-31

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
30ab7b30-cc90-4b84-8caf-21058f1d37faAvailable 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
71337-046-01DICLOFENAC POTASSIUM100 in 1 BOTTLETABLET1001
71337-046-05DICLOFENAC POTASSIUM500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71337-046DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM, FILM COATED) TABLET [HAVIX GROUP INC D-B-A AAVIS PHARMACEUTICALS]1Current NDC, 2 package rows20230629_30ab7b30-cc90-4b84-8caf-21058f1d37fa.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 · 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
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
ndc (product): 71337-046

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN30ab7b30-cc90-4b84-8caf-21058f1d37fa1
855942diclofenac potassium 50 MG Oral TabletSCD30ab7b30-cc90-4b84-8caf-21058f1d37fa1
855942Diclofenac K+ 50 MG Oral TabletSY30ab7b30-cc90-4b84-8caf-21058f1d37fa1
855942Diclofenac Pot 50 MG Oral TabletSY30ab7b30-cc90-4b84-8caf-21058f1d37fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71337-046-0171337004601100 TABLET in 1 BOTTLE (71337-046-01) 100 tablet2023-06-26NoNoCurrent
71337-046-0571337004605500 TABLET in 1 BOTTLE (71337-046-05) 500 tablet2023-06-26NoNoCurrent