Diflunisal

Product NDC: 62135-456
11-digit product format: 621350456
Labeler code: 62135
Product ID: 62135-456_242086f3-3373-fac8-e063-6394a90a82ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diflunisal
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA202845
Marketing category: ANDA
Marketing start: 2012-03-08
Substance: DIFLUNISAL
Active strength: 500 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202845-001	DIFLUNISAL	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08
A202845-002	DIFLUNISAL	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16
A202845-003	DIFLUNISAL	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202845-001	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 · 63 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	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A202845-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202845-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202845-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202845-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202845-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202845-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202845-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202845-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202845-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202845-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202845-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202845-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202845-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202845-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202845-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202845-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202845-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202845-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202845-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202845-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202845-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202845-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202845-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202845-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202845-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202845-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202845-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202845-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202845-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202845-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202845-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202845-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202845-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202845-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202845-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202845-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202845-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202845-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202845-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202845-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diflunisal
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIFLUNISAL	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7C546U4DEN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197603	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
2043bab8-87c9-45ce-88c7-383f0d4c4b64	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2323d3f0-80b8-7ff4-d997-b3ca46ce553a	Product name	2	20170802

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62135-456-60	Diflunisal	60 in 1 BOTTLE	TABLET, FILM COATED	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-456-60	EA - Each	62135-456	3e9d89b4-a682-41f5-9e62-7ce8d3293490	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-456	DIFLUNISAL TABLET, FILM COATED [CHARTWELL RX, LLC]	2	Current NDC, 1 package rows	20241012_2043bab8-87c9-45ce-88c7-383f0d4c4b64.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolobid	DIFLUNISAL	INA Pharmaceutics Inc	725234b2-0e23-45c3-a42d-eb4e62273f9b	2025-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202845 application number: ANDA202845
Diflunisal	DIFLUNISAL	Chartwell RX, LLC	2043bab8-87c9-45ce-88c7-383f0d4c4b64	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202845 application number: ANDA202845 ndc (product): 62135-456
diflunisal	DIFLUNISAL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	666f89b4-fd81-420a-a390-eb1cd4014f61	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202845 application number: ANDA202845

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7C546U4DEN	DIFLUNISAL	22494-42-4	DIFLUNISAL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197603	diflunisal 500 MG Oral Tablet	PSN	2043bab8-87c9-45ce-88c7-383f0d4c4b64	2
197603	diflunisal 500 MG Oral Tablet	SCD	2043bab8-87c9-45ce-88c7-383f0d4c4b64	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
62135-456-60	62135045660	60 TABLET, FILM COATED in 1 BOTTLE (62135-456-60)	2023-01-31	No	No	Current