Diclofenac Potassium

Product NDC: 70934-906
Requested package NDC: 70934-906-30
11-digit product format: 709340906
Labeler code: 70934
Product ID: 70934-906_cd898f04-084e-4c25-e053-2995a90a95ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA076561
Marketing category: ANDA
Marketing start: 2021-10-04
Marketing end: 0000-00-00
Substance: DICLOFENAC POTASSIUM
Active strength: 50 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70934-906	70934-906-30	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076561-001	CATAFLAM	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		2004-03-18
A076561-002	CATAFLAM	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076561-001	AB
A076561-002	AB

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 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076561-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2004-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076561-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2004-03-18	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076561-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076561-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076561-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076561-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076561-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076561-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076561-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076561-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076561-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076561-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076561-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076561-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076561-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076561-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076561-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076561-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076561-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076561-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076561-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076561-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076561-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076561-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076561-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076561-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076561-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076561-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076561-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076561-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076561-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076561-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076561-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076561-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076561-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076561-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076561-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076561-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076561-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076561-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076561-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076561-001	AB	1	`87673890dc5c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Potassium	DICLOFENAC POTASSIUM	Golden State Medical Supply, Inc.	c2c79af6-f35e-5cdf-e053-2a95a90a4d63	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076561 application number: ANDA076561
Diclofenac Potassium	DICLOFENAC POTASSIUM	Amici Pharma Inc.	f2908870-a517-491f-8771-4100d11b4b64	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076561 application number: ANDA076561
LOFENA	DICLOFENAC POTASSIUM	Carwin Pharmaceutical Associates, LLC	49bd64cc-5edb-44f2-8e24-1249f6a76663	2024-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076561 application number: ANDA076561
Diclofenac Potassium	DICLOFENAC POTASSIUM	Carwin Pharmaceutical Associates, LLC	bce95bb3-3097-4e7d-8d29-0870bb729212	2023-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076561 application number: ANDA076561

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L4D5UA6CB4	DICLOFENAC POTASSIUM	15307-81-0	DICLOFENAC POTASSIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-906-30	70934090630	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-906-30)	2021-10-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Potassium Tablets, USP 50mg	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-10-04	HUMAN PRESCRIPTION DRUG LABEL	1