Ketoprofen

Product NDC: 0276-0504
11-digit product format: 002760504
Labeler code: 0276
Product ID: 0276-0504_4add4a71-ad1b-2577-e063-6294a90a3263
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoprofen
Dosage form: CAPSULE
Route: ORAL
Labeler: Misemer Pharmaceuticals, Inc.
Application: ANDA074014
Marketing category: ANDA
Marketing start: 2019-06-19
Substance: KETOPROFEN
Active strength: 25 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: Ketoprofen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOPROFEN	25 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197854	Internal RxNorm lookup
197855	Internal RxNorm lookup
197856	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
d0f47ab6-29ff-df07-e053-2a95a90a2b51	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0276-0504-10	2024-02-01	C162847	48780-1	1030e365-5724-111a-e063-dadaa90a10e2	KETOPROFEN CAPSULES USP
0276-0504-10	2024-01-30	C162847	48780-1	1030e365-5724-111a-e063-dadaa90a10e2	KETOPROFEN CAPSULES USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0276-0504-10	Ketoprofen	100 in 1 BOTTLE	CAPSULE	100		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0276-0504-10	EA - Each	0276-0504	b76d087e-0eca-455a-95b7-7f660e6220cc	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0276-0504	KETOPROFEN CAPSULE [MISEMER PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20240731_d0f47ab6-29ff-df07-e053-2a95a90a2b51.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
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 ndc (product): 0276-0504
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

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
197854	ketoprofen 25 MG Oral Capsule	PSN	d0f47ab6-29ff-df07-e053-2a95a90a2b51	11
197855	ketoprofen 50 MG Oral Capsule	PSN	d0f47ab6-29ff-df07-e053-2a95a90a2b51	11
197856	ketoprofen 75 MG Oral Capsule	PSN	d0f47ab6-29ff-df07-e053-2a95a90a2b51	11
197854	ketoprofen 25 MG Oral Capsule	SCD	d0f47ab6-29ff-df07-e053-2a95a90a2b51	11
197855	ketoprofen 50 MG Oral Capsule	SCD	d0f47ab6-29ff-df07-e053-2a95a90a2b51	11
197856	ketoprofen 75 MG Oral Capsule	SCD	d0f47ab6-29ff-df07-e053-2a95a90a2b51	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0276-0504-10	00276050410	100 CAPSULE in 1 BOTTLE (0276-0504-10)	100 capsule	2021-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KETOPROFEN CAPSULES USP	Misemer Pharmaceuticals, Inc.	2026-02-15	HUMAN PRESCRIPTION DRUG LABEL	11