Orudis

Product NDC: 28595-031
Requested package NDC: 28595-031-60
11-digit product format: 285950031
Labeler code: 28595
Product ID: 28595-031_47d0b2fe-e786-c7a7-e063-6394a90a3b3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoprofen
Dosage form: CAPSULE
Route: ORAL
Labeler: Allegis Pharmaceuticals, Inc.
Application: ANDA074014
Marketing category: ANDA
Marketing start: 2026-01-07
Substance: KETOPROFEN
Active strength: 75 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: 2027-12-31
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	RLD / RS	Approval date
A074014-001	KETOPROFEN	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29
A074014-002	KETOPROFEN	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29
A074014-003	KETOPROFEN	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074014-002	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 49 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	A074014-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074014-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074014-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074014-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074014-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074014-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074014-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074014-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074014-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074014-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074014-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074014-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074014-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074014-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074014-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074014-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074014-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074014-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074014-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074014-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074014-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074014-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074014-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074014-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074014-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074014-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074014-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074014-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074014-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074014-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074014-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074014-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074014-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074014-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074014-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074014-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074014-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074014-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074014-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074014-002	AB	1	`9b2671bbb829…`

Additional Listing Data#

Finished product: Yes
Brand name base: Orudis
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOPROFEN	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
90Y4QC304K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197856	Internal RxNorm lookup
206992	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
47d0b808-7142-c7a9-e063-6394a90a6e0d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
460c0bb5-c2b5-c96e-0f79-68a0385a39a0	Product name	2	20201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
28595-031-60	Orudis	60 in 1 BOTTLE	CAPSULE	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
28595-031-60	EA - Each	28595-031	3fcc23c7-d8f2-4b91-b894-00cefddfa904	1	2026-02-05

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
Ketoprofen	KETOPROFEN	Marnel Pharmaceuticals, Inc.	4e7bceb6-dcb5-c5e0-e063-6294a90a101e	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074014 application number: ANDA074014
Ketoprofen	KETOPROFEN	Oncora Pharma, LLC	492de5dc-7c1b-47be-8510-43be4e1fd4ed	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074014 application number: ANDA074014
Ketoprofen	KETOPROFEN	Misemer Pharmaceuticals, Inc.	d0f47ab6-29ff-df07-e053-2a95a90a2b51	2026-02-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074014 application number: ANDA074014
Orudis	KETOPROFEN	Allegis Pharmaceuticals, Inc.	47d0b808-7142-c7a9-e063-6394a90a6e0d	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074014 application number: ANDA074014 ndc (package): 28595-031-60 ndc (product): 28595-031 ndc11 (package): 28595003160

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
90Y4QC304K	KETOPROFEN	22071-15-4	KETOPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197856	ketoprofen 75 MG Oral Capsule	PSN	47d0b808-7142-c7a9-e063-6394a90a6e0d	1
206992	Orudis 75 MG Oral Capsule	PSN	47d0b808-7142-c7a9-e063-6394a90a6e0d	1
206992	ketoprofen 75 MG Oral Capsule [Orudis]	SBD	47d0b808-7142-c7a9-e063-6394a90a6e0d	1
197856	ketoprofen 75 MG Oral Capsule	SCD	47d0b808-7142-c7a9-e063-6394a90a6e0d	1
206992	Orudis 75 MG Oral Capsule	SY	47d0b808-7142-c7a9-e063-6394a90a6e0d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
28595-031-60	28595003160	60 CAPSULE in 1 BOTTLE (28595-031-60)	60 capsule	2026-01-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ORUDIS (KETOPROFEN) CAPSULES USP	Allegis Pharmaceuticals, Inc.	2026-01-07	HUMAN PRESCRIPTION DRUG LABEL	1