FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
72162-1733
11-digit product format
721621733
Labeler code
72162
Product ID
72162-1733_32b578e0-6567-473c-894a-b8ba9d59b4b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075185
Marketing category
ANDA
Marketing start
1998-11-13
Substance
DICLOFENAC SODIUM
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 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
A075185-001DICLOFENAC SODIUMDICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13
A075185-002DICLOFENAC SODIUMDICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13
A075185-003DICLOFENAC SODIUMDICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075185-001AB
A075185-002AB
A075185-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-1384e616aacf4f…
2026-09-14 22:38:342026-08A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-1384e616aacf4f…
2026-09-14 22:38:342026-08A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-1384e616aacf4f…
2026-08-18 06:07:402026-07A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13caaa826d4ba7…
2026-08-18 06:07:402026-07A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13caaa826d4ba7…
2026-08-18 06:07:402026-07A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075185-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075185-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A075185-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A075185-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075185-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075185-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075185-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075185-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075185-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075185-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075185-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075185-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075185-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075185-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075185-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075185-001AB1301d65b070ca…

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
Brand name suffix
Delayed Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM50 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
12cce748-a7de-4b1e-9603-b5c2ce12d531Available 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
72162-1733-0Diclofenac Sodium Delayed Release1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1000104
72162-1733-1Diclofenac Sodium Delayed Release100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE100104
72162-1733-2Diclofenac Sodium Delayed Release120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE120104
72162-1733-3Diclofenac Sodium Delayed Release30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE30104
72162-1733-6Diclofenac Sodium Delayed Release60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE60104
72162-1733-7Diclofenac Sodium Delayed Release14 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE14104
72162-1733-8Diclofenac Sodium Delayed Release1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1000104
72162-1733-9Diclofenac Sodium Delayed Release90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE90104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1733-0EA - Each72162-1733aa04f0bd-5c06-4deb-a27c-2b318f1558f912024-09-09
72162-1733-1EA - Each72162-1733f2aa2943-d588-488d-9659-86b39602e46212023-12-05
72162-1733-2EA - Each72162-1733ff0744fe-e6b3-45ab-8c87-e80318c5181012023-10-16
72162-1733-3EA - Each72162-17332f9daf7f-5df7-4d45-be8e-2174b4121fb212023-10-16
72162-1733-6EA - Each72162-17332d6c588d-9fb4-4716-84e6-9708ed71e3ef12023-10-16
72162-1733-7EA - Each72162-17336b0217fb-d65e-4410-bf23-d6ee95a5e8ac12023-10-16
72162-1733-8EA - Each72162-17336524868f-b35e-4c1a-ac9f-330496d2746612024-09-09
72162-1733-9EA - Each72162-17338a3b48b6-9810-4447-9646-8e7e0a10345e12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1733DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]104Current NDC, 8 package rows20240829_12cce748-a7de-4b1e-9603-b5c2ce12d531.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 3 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack7c3d8d33-8849-44df-bb57-57d32b96a0e42024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepackbced0ef0-085a-40db-9678-2bc6eb77d4562024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepacke6a1ff58-a541-46f8-9663-eed53b7cf3922023-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions9df87100-acf5-4b46-93b4-067b470136bd2023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LP73a46413-ecbc-4453-814d-bec955b375d22023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LPafce2de2-0c59-4191-bf79-782ca31e427d2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LP947c0c1f-3573-4f69-ab82-8b50c43e55862022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN12cce748-a7de-4b1e-9603-b5c2ce12d531104
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD12cce748-a7de-4b1e-9603-b5c2ce12d531104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1733-0721621733001000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-0) 2024-08-12NoNoCurrent
72162-1733-172162173301100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-1) 2024-08-12NoNoCurrent
72162-1733-272162173302120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-2) 2024-08-12NoNoCurrent
72162-1733-37216217330330 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-3) 2024-08-12NoNoCurrent
72162-1733-67216217330660 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-6) 2024-08-12NoNoCurrent
72162-1733-77216217330714 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-7) 2024-08-12NoNoCurrent
72162-1733-8721621733081000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-8) 2024-08-12NoNoCurrent
72162-1733-97216217330990 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-9) 2024-08-12NoNoCurrent