Ketoprofen

Product NDC: 0378-8200
11-digit product format: 003788200
Labeler code: 0378
Product ID: 0378-8200_2dad8626-e0dd-46ad-9e75-069c6e82fc20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketoprofen
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA075679
Marketing category: ANDA
Marketing start: 2003-09-04
Substance: KETOPROFEN
Active strength: 200 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	RLD / RS	Approval date
A075679-001	KETOPROFEN	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20
A075679-002	KETOPROFEN	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20
A075679-003	KETOPROFEN	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOPROFEN	200 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
359697	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
198a4140-f4c0-4478-9157-ee1d68d0bb96	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
0378-8200-01	Ketoprofen	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-8200-01	EA - Each	0378-8200	c6ddd38f-7b5b-425f-ad0a-fb20cea13c7d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
KETOPROFEN	ACTIVE INGREDIENT	90Y4QC304K	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
KETOPROFEN	ACTIVE MOIETY	90Y4QC304K	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
SHELLAC	INACTIVE INGREDIENT	46N107B71O	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	8
KETOPROFEN	ACTIVE INGREDIENT	90Y4QC304K	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
KETOPROFEN	ACTIVE MOIETY	90Y4QC304K	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	KETOPROFEN CAPSULE KETOPROFEN CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-8200	KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	19	Current NDC, Legacy NDC, 1 package rows	20241109_198a4140-f4c0-4478-9157-ee1d68d0bb96.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoprofen	KETOPROFEN	Mylan Pharmaceuticals Inc.	198a4140-f4c0-4478-9157-ee1d68d0bb96	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075679 application number: ANDA075679 ndc (product): 0378-8200

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
359697	ketoprofen 200 MG 24HR Extended Release Oral Capsule	PSN	198a4140-f4c0-4478-9157-ee1d68d0bb96	19
359697	24 HR ketoprofen 200 MG Extended Release Oral Capsule	SCD	198a4140-f4c0-4478-9157-ee1d68d0bb96	19
359697	ketoprofen 200 MG 24 HR Extended Release Oral Capsule	SY	198a4140-f4c0-4478-9157-ee1d68d0bb96	19
359697	ketoprofen 200 MG 24HR Extended Release Oral Capsule	PSN	b3180408-a3c0-4e02-8535-dea390a52277	7
197855	ketoprofen 50 MG Oral Capsule	PSN	b3180408-a3c0-4e02-8535-dea390a52277	7
197856	ketoprofen 75 MG Oral Capsule	PSN	b3180408-a3c0-4e02-8535-dea390a52277	7
359697	24 HR ketoprofen 200 MG Extended Release Oral Capsule	SCD	b3180408-a3c0-4e02-8535-dea390a52277	7
197855	ketoprofen 50 MG Oral Capsule	SCD	b3180408-a3c0-4e02-8535-dea390a52277	7
197856	ketoprofen 75 MG Oral Capsule	SCD	b3180408-a3c0-4e02-8535-dea390a52277	7
359697	ketoprofen 200 MG 24 HR Extended Release Oral Capsule	SY	b3180408-a3c0-4e02-8535-dea390a52277	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-8200-01	00378820001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-8200-01)	2003-09-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketoprofen Extended-Release Capsules, USP 200 mg	Mylan Pharmaceuticals Inc.	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	19
Ketoprofen - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2012-06-26	HUMAN PRESCRIPTION DRUG LABEL	7