Ketorolac Tromethamine

Product NDC: 0378-1134
11-digit product format: 003781134
Labeler code: 0378
Product ID: 0378-1134_a2e96323-5726-45ce-9e73-f143f122b06b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketorolac Tromethamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA074761
Marketing category: ANDA
Marketing start: 2013-05-16
Substance: KETOROLAC TROMETHAMINE
Active strength: 10 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], 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: Ketorolac Tromethamine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOROLAC TROMETHAMINE	10 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	4EVE5946BQ
Rxcui	834022

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a38bd75-79e3-96c0-1204-08a0282902ae	Product name	4	20250128
4d6e22a5-3693-6edf-0179-2ab93aecbadb	Product name	9	20240724
03452e68-2506-686e-a908-f2381c778fc6	Product name	5	20240307
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
bb41bc3a-c643-93c9-055f-a8f48f363af3	Product name	2	20190219
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70c	Product name	1	20140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-1134-01	Ketorolac Tromethamine	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1134-01	EA - Each	0378-1134	c08b8527-ff6f-4563-bbcd-685c14aae423	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-1134	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	16	Current NDC, Legacy NDC, 1 package rows	20241004_2837a082-3a34-6f81-5e43-45a70295686b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4EVE5946BQ	KETOROLAC TROMETHAMINE	74103-07-4	KETOROLAC TROMETHAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	2837a082-3a34-6f81-5e43-45a70295686b	16
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	2837a082-3a34-6f81-5e43-45a70295686b	16
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	2f4057b1-4707-4975-949e-3d62133d96f9	5
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	2f4057b1-4707-4975-949e-3d62133d96f9	5
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	bc2f7fc4-698e-1286-e053-2a95a90a188e	3
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	bc2f7fc4-698e-1286-e053-2a95a90a188e	3
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	a41b9710-a1ec-41be-8417-b03c5d802ae2	1
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	dce94664-7e3d-4592-86ac-2a94231e484b	1
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	e61ae711-e6d2-44e4-b7d7-943a9d06f985	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	a41b9710-a1ec-41be-8417-b03c5d802ae2	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	dce94664-7e3d-4592-86ac-2a94231e484b	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	e61ae711-e6d2-44e4-b7d7-943a9d06f985	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-1134-01	00378113401	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1134-01)	2013-05-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketorolac Tromethamine Tablets, USP 10 mg	Mylan Pharmaceuticals Inc.	2024-08-31	HUMAN PRESCRIPTION DRUG LABEL	16
Ketorolac 10mg tabs	RedPharm Drug, Inc. \| RedPharm Drug	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	3
Ketorolac Tromethamine - ReadyMeds	ReadyMeds	2014-05-15	HUMAN PRESCRIPTION DRUG LABEL	5
KETOTOLAC TROMETHAMINE - STAT Rx USA LLC \| PSS World Medical Inc.	STAT Rx USA LLC \| PSS World Medical Inc.	2012-04-11	HUMAN PRESCRIPTION DRUG LABEL	1
KETOROLAC - STAT RX USA LLC	STAT RX USA LLC	2011-08-16	HUMAN PRESCRIPTION DRUG LABEL	1
Ketorolac Tromethamine - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-03-17	HUMAN PRESCRIPTION DRUG LABEL	1

Ketorolac Tromethamine

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#