Diclofenac Sodium

Product NDC
72888-111
11-digit product format
728880111
Labeler code
72888
Product ID
72888-111_3904a832-bc2f-1d96-e063-6294a90a0cd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA216548
Marketing category
ANDA
Marketing start
2023-05-11
Substance
DICLOFENAC SODIUM
Active strength
75 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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216548-001DICLOFENAC SODIUMDICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-11
A216548-002DICLOFENAC SODIUMDICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2023-05-11
A216548-003DICLOFENAC SODIUMDICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2023-05-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A216548-001AB
A216548-002AB
A216548-003AB

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 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A216548-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A216548-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2023-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A216548-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2023-05-1184e616aacf4f…
2026-08-18 06:07:402026-07A216548-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A216548-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2023-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A216548-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2023-05-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216548-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216548-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2023-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216548-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2023-05-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216548-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216548-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2023-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216548-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2023-05-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216548-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216548-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2023-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216548-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2023-05-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216548-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216548-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2023-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216548-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2023-05-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216548-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216548-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2023-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216548-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2023-05-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216548-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216548-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2023-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216548-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2023-05-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216548-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216548-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2023-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216548-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2023-05-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216548-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216548-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2023-05-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216548-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2023-05-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216548-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216548-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2023-05-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216548-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2023-05-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216548-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A216548-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2023-05-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A216548-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2023-05-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216548-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216548-002DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB2023-05-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216548-003DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB2023-05-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216548-001DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB2023-05-11301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216548-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A216548-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A216548-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A216548-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216548-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216548-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216548-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216548-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216548-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216548-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216548-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216548-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216548-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216548-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216548-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216548-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216548-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216548-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216548-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216548-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216548-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216548-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216548-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216548-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216548-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216548-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216548-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216548-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216548-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216548-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216548-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216548-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216548-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216548-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216548-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216548-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216548-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216548-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216548-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216548-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QTG126297QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855664Internal RxNorm lookup
855906Internal RxNorm lookup
855926Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac2b4060-a5da-4ddf-a734-2ff58a1f98c9Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
72888-111-00Diclofenac Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE10004
72888-111-01Diclofenac Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE1004
72888-111-05Diclofenac Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE5004
72888-111-30Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE304
72888-111-60Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-111-00EA - Each72888-111fcfbeae5-3d19-4bf6-b4b9-d22645bcb71a12023-07-06
72888-111-01EA - Each72888-1113771d875-7eec-4fa9-a525-af5145482c4412023-07-06
72888-111-05EA - Each72888-111aaf5d770-d15f-47f5-8c4b-b147964bed8412023-08-08
72888-111-60EA - Each72888-1111dff1fee-f608-4895-a60c-692b3e61ff2f12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-111DICLOFENAC SODIUM TABLET, DELAYED RELEASE [ADVAGEN PHARMA LTD]3Current NDC, 5 package rows20230929_ac2b4060-a5da-4ddf-a734-2ff58a1f98c9.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions337c2253-34c1-4611-88c9-d558507255a22026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216548
application number: ANDA216548
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack03c4f06f-6a49-4404-bf3b-0aafa33c81ef2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216548
application number: ANDA216548
Diclofenac SodiumDICLOFENAC SODIUMRedpharm Drug325213a3-241c-18d2-e063-6394a90a40f72025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216548
application number: ANDA216548
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions4c5b722e-0d1a-48e9-87c8-9b370b8ced462025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216548
application number: ANDA216548
Diclofenac SodiumDICLOFENAC SODIUMAdvagen Pharma Ltdac2b4060-a5da-4ddf-a734-2ff58a1f98c92025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216548
application number: ANDA216548
ndc (product): 72888-111
Diclofenac SodiumDICLOFENAC SODIUMNorthStar Rx LLCc7431496-c0ef-403a-9716-92d942709b3d2025-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216548
application number: ANDA216548

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855664diclofenac sodium 25 MG Delayed Release Oral TabletPSNac2b4060-a5da-4ddf-a734-2ff58a1f98c94
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNac2b4060-a5da-4ddf-a734-2ff58a1f98c94
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN325213a3-241c-18d2-e063-6394a90a40f74
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNac2b4060-a5da-4ddf-a734-2ff58a1f98c94
855664diclofenac sodium 25 MG Delayed Release Oral TabletSCDac2b4060-a5da-4ddf-a734-2ff58a1f98c94
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDac2b4060-a5da-4ddf-a734-2ff58a1f98c94
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD325213a3-241c-18d2-e063-6394a90a40f74
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDac2b4060-a5da-4ddf-a734-2ff58a1f98c94
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN03c4f06f-6a49-4404-bf3b-0aafa33c81ef1
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD03c4f06f-6a49-4404-bf3b-0aafa33c81ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72888-111-00728880111001000 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-00) 2023-06-01NoNoCurrent
72888-111-0172888011101100 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-01) 2023-06-01NoNoCurrent
72888-111-0572888011105500 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-05) 2023-08-01NoNoCurrent
72888-111-307288801113030 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-30) 2023-06-01NoNoCurrent
72888-111-607288801116060 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-60) 2023-06-01NoNoCurrent