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

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 Identifiers#

Field, Values table
Field	Values
Unii	90Y4QC304K
Rxcui	359697

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

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

Ketoprofen

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#