LOFENA

Product NDC: 15370-180
11-digit product format: 153700180
Labeler code: 15370
Product ID: 15370-180_2a1bac02-dabb-4afe-a378-bc4451dcb0cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DICLOFENAC POTASSIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Carwin Pharmaceutical Associates, LLC
Application: ANDA076561
Marketing category: ANDA
Marketing start: 2021-10-25
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 43.

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 · 78 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
2026-09-14 22:38:34	2026-08	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076561-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076561-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076561-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076561-002	AB	1	`caaa826d4ba7…`
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…`

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: LOFENA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC POTASSIUM	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L4D5UA6CB4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
857702	Internal RxNorm lookup
2584350	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
49bd64cc-5edb-44f2-8e24-1249f6a76663	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
15370-180-10	LOFENA	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		3
15370-180-60	LOFENA	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
15370-180-60	EA - Each	15370-180	714cb56c-6b7c-49b9-b72e-8ffbef017456	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15370-180	LOFENA (DICLOFENAC POTASSIUM) TABLET, FILM COATED [CARWIN PHARMACEUTICAL ASSOCIATES, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20250410_49bd64cc-5edb-44f2-8e24-1249f6a76663.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 · 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 ndc (product): 15370-180
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857702	diclofenac potassium 25 MG Oral Tablet	PSN	f2908870-a517-491f-8771-4100d11b4b64	9
855942	diclofenac potassium 50 MG Oral Tablet	PSN	f2908870-a517-491f-8771-4100d11b4b64	9
857702	diclofenac potassium 25 MG Oral Tablet	SCD	f2908870-a517-491f-8771-4100d11b4b64	9
855942	diclofenac potassium 50 MG Oral Tablet	SCD	f2908870-a517-491f-8771-4100d11b4b64	9
857702	Diclofenac K+ 25 MG Oral Tablet	SY	f2908870-a517-491f-8771-4100d11b4b64	9
855942	Diclofenac K+ 50 MG Oral Tablet	SY	f2908870-a517-491f-8771-4100d11b4b64	9
857702	Diclofenac Pot 25 MG Oral Tablet	SY	f2908870-a517-491f-8771-4100d11b4b64	9
855942	Diclofenac Pot 50 MG Oral Tablet	SY	f2908870-a517-491f-8771-4100d11b4b64	9
857702	diclofenac potassium 25 MG Oral Tablet	PSN	49bd64cc-5edb-44f2-8e24-1249f6a76663	3
2584350	LOFENA 25 MG Oral Tablet	PSN	49bd64cc-5edb-44f2-8e24-1249f6a76663	3
2584350	diclofenac potassium 25 MG Oral Tablet [Lofena]	SBD	49bd64cc-5edb-44f2-8e24-1249f6a76663	3
857702	diclofenac potassium 25 MG Oral Tablet	SCD	49bd64cc-5edb-44f2-8e24-1249f6a76663	3
857702	Diclofenac K+ 25 MG Oral Tablet	SY	49bd64cc-5edb-44f2-8e24-1249f6a76663	3
2584350	diclofenac K+ 25 MG Oral Tablet [Lofena]	SY	49bd64cc-5edb-44f2-8e24-1249f6a76663	3
857702	Diclofenac Pot 25 MG Oral Tablet	SY	49bd64cc-5edb-44f2-8e24-1249f6a76663	3
2584350	diclofenac Pot 25 MG Oral Tablet [Lofena]	SY	49bd64cc-5edb-44f2-8e24-1249f6a76663	3
2584350	Lofena 25 MG Oral Tablet	SY	49bd64cc-5edb-44f2-8e24-1249f6a76663	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
15370-180-10	15370018010	1000 TABLET, FILM COATED in 1 BOTTLE (15370-180-10)	2021-10-25	0000-00-00	No	No	Current
15370-180-60	15370018060	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-180-60)	2021-10-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Potassium Tablets, USP 50mg	Amici Pharma Inc. \| Frontida BioPharm, LLC \| Nutra-Med Packaging, Inc	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	9
LOFENA™ (diclofenac potassium tablets, USP)	Carwin Pharmaceutical Associates, LLC	2024-01-08	HUMAN PRESCRIPTION DRUG LABEL	3