Ketorolac Tromethamine

Product NDC: 0093-0314
Requested package NDC: 0093-0314-01
11-digit product format: 000930314
Labeler code: 0093
Product ID: 0093-0314_06cd0a02-e137-4ae7-9f76-a416efe1f191
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketorolac Tromethamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA074754
Marketing category: ANDA
Marketing start: 1998-06-17
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074754-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074754-001	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.

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
2026-08-01 22:54:32	2026-06	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A074754-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	f47d4365-40a8-445b-99cd-49edad6a8ffc	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Sportpharm LLC	0749f61d-12e6-4280-8f41-bd4df81e7ae6	2026-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Northwind Health Company, LLC	d17ed469-677b-4a2e-96a9-5cfd0f50ecd9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	American Health Packaging	48244614-53ec-47e6-ad48-50814bdcceb7	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	PD-Rx Pharmaceuticals, Inc.	add10ccd-c205-4512-9619-253290fa1152	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	9fdba2e6-969f-4624-b08b-a42f99e4eff9	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Advanced Rx Pharmacy of Tennessee, LLC	c1717245-cef3-b3d7-e053-2a95a90a1ac5	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Teva Pharmaceuticals USA, Inc.	688f5dec-a6db-43c6-a1f8-5df99d08d395	2024-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754 ndc (package): 0093-0314-01 ndc (product): 0093-0314 ndc11 (package): 00093031401
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals, Inc.	415a5393-296f-30e3-e054-00144ff8d46c	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals, Inc.	46dc8f62-e754-50e3-e054-00144ff8d46c	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	f713500a-20b8-8e20-c4cc-956805170335	2023-11-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Asclemed USA, Inc.	94c7c57a-fd1e-41ab-bc39-9a538f6011d1	2023-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Proficient Rx LP	f5170993-81a9-4eb7-95ac-60697a5ee1d7	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4EVE5946BQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
834022	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
688f5dec-a6db-43c6-a1f8-5df99d08d395	Available on FDA.report

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
0093-0314-01	Ketorolac Tromethamine	100 in 1 BOTTLE	TABLET, FILM COATED	100		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-0314-01	EA - Each	0093-0314	f1d46331-31b6-47a5-bff1-0d119d52afcd	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 [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3904
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3904
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3904
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3904
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3904
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3904
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3904
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3904
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3904
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	9
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	9
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	9
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	KETOROLAC TROMETHAMINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	9
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	KETOROLAC TROMETHAMINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	9
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	9
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	2
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX]	2
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX]	2
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
KETOROLAC TROMETHAMINE	ACTIVE MOIETY	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	1
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]	1
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
KETOROLAC TROMETHAMINE	ACTIVE MOIETY	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
KETOROLAC TROMETHAMINE	ACTIVE MOIETY	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-0314	KETOROLAC TROMETHAMINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	19	Current NDC, Legacy NDC, 1 package rows	20250106_688f5dec-a6db-43c6-a1f8-5df99d08d395.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	f47d4365-40a8-445b-99cd-49edad6a8ffc	25
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	f47d4365-40a8-445b-99cd-49edad6a8ffc	25
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	add10ccd-c205-4512-9619-253290fa1152	24
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	add10ccd-c205-4512-9619-253290fa1152	24
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	688f5dec-a6db-43c6-a1f8-5df99d08d395	19
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	688f5dec-a6db-43c6-a1f8-5df99d08d395	19
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	9fdba2e6-969f-4624-b08b-a42f99e4eff9	17
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	9fdba2e6-969f-4624-b08b-a42f99e4eff9	17
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	f713500a-20b8-8e20-c4cc-956805170335	9
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	f713500a-20b8-8e20-c4cc-956805170335	9
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	f5170993-81a9-4eb7-95ac-60697a5ee1d7	7
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	f5170993-81a9-4eb7-95ac-60697a5ee1d7	7
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	46dc8f62-e754-50e3-e054-00144ff8d46c	6
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	a42517a0-245e-44ec-b9fc-cf4e4b4a8989	6
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	4af70eae-71ca-65f2-e054-00144ff88e88	6
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	46dc8f62-e754-50e3-e054-00144ff8d46c	6
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	a42517a0-245e-44ec-b9fc-cf4e4b4a8989	6
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	4af70eae-71ca-65f2-e054-00144ff88e88	6
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	a5220202-6eee-4a42-8d4a-8f7475dd1383	5
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	c1717245-cef3-b3d7-e053-2a95a90a1ac5	5
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	a5220202-6eee-4a42-8d4a-8f7475dd1383	5
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	c1717245-cef3-b3d7-e053-2a95a90a1ac5	5
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	48244614-53ec-47e6-ad48-50814bdcceb7	4
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	d17ed469-677b-4a2e-96a9-5cfd0f50ecd9	4
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	415a5393-296f-30e3-e054-00144ff8d46c	4
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	40d145e6-13f7-41ac-e054-00144ff8d46c	4
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	415a5393-296f-30e3-e054-00144ff8d46c	4
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	40d145e6-13f7-41ac-e054-00144ff8d46c	4
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	48244614-53ec-47e6-ad48-50814bdcceb7	4
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	d17ed469-677b-4a2e-96a9-5cfd0f50ecd9	4
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	0749f61d-12e6-4280-8f41-bd4df81e7ae6	3
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	94c7c57a-fd1e-41ab-bc39-9a538f6011d1	3
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	19300bc5-39ba-47b7-bfda-036b0a2649ae	3
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	0749f61d-12e6-4280-8f41-bd4df81e7ae6	3
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	94c7c57a-fd1e-41ab-bc39-9a538f6011d1	3
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	19300bc5-39ba-47b7-bfda-036b0a2649ae	3
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	9a6df709-e016-44e1-8e1d-dea46689c3c8	2
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	1191f151-ab29-1f7e-e054-00144ff88e88	2
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	e20df5b6-84da-4715-b36e-bb7e4be55416	2
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	9a6df709-e016-44e1-8e1d-dea46689c3c8	2
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	1191f151-ab29-1f7e-e054-00144ff88e88	2
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	e20df5b6-84da-4715-b36e-bb7e4be55416	2
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	a2b0b02e-a345-44c3-afb8-6b99bf646547	1
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	11b38f8d-26e0-4614-97ba-722505b0ffb0	1
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	dff04c8d-6043-6ef0-e053-2995a90aa42f	1
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	434b9c9c-8831-4e15-8802-a29c8ee269af	1
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	b701aef5-3f70-4bc2-abe7-7047b6a6e2a5	1
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	5914ef00-19b1-4e22-9ad3-2b62b455af9d	1
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	720592fe-37b0-75c1-e053-2a95a90af983	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	dff04c8d-6043-6ef0-e053-2995a90aa42f	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	434b9c9c-8831-4e15-8802-a29c8ee269af	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	5914ef00-19b1-4e22-9ad3-2b62b455af9d	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	b701aef5-3f70-4bc2-abe7-7047b6a6e2a5	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	11b38f8d-26e0-4614-97ba-722505b0ffb0	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	720592fe-37b0-75c1-e053-2a95a90af983	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	a2b0b02e-a345-44c3-afb8-6b99bf646547	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-0314-01	00093031401	100 TABLET, FILM COATED in 1 BOTTLE (0093-0314-01)	1998-06-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketorolac Tromethamine Tablets USP, 10 mg Rx only	REMEDYREPACK INC.	2026-06-22	HUMAN PRESCRIPTION DRUG LABEL	26
Ketorolac Tromethamine Tablets USP, 10 mg Rx only	Sportpharm LLC	2026-04-05	HUMAN PRESCRIPTION DRUG LABEL	3
Ketorolac Tromethamine Tablets USP, 10 mg Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Ketorolac Tromethamine Tablets USP 8410421/0725 Rx Only	American Health Packaging	2025-08-28	HUMAN PRESCRIPTION DRUG LABEL	4
Ketorolac Tromethamine Tablets USP, 10 mg Rx only	PD-Rx Pharmaceuticals, Inc.	2025-03-12	HUMAN PRESCRIPTION DRUG LABEL	24
Ketorolac Tromethamine Tablets USP, 10 mg Rx only	A-S Medication Solutions	2025-02-06	HUMAN PRESCRIPTION DRUG LABEL	17
Ketorolac Tromethamine Tablet	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	5
Ketorolac Tromethamine Tablets USP, 10 mg Rx only	Teva Pharmaceuticals USA, Inc.	2024-12-12	HUMAN PRESCRIPTION DRUG LABEL	19
KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only	NuCare Pharmaceuticals, Inc.	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	6
KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only	NuCare Pharmaceuticals, Inc.	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	4
Ketorolac Tromethamine Tablets USP, 10 mg Rx only	Preferred Pharmaceuticals Inc.	2024-06-05	HUMAN PRESCRIPTION DRUG LABEL	3
Ketorolac Tromethamine Tablets USP, 10 mg Rx only	Bryant Ranch Prepack	2023-11-28	HUMAN PRESCRIPTION DRUG LABEL	9
KETOROLAC TROMETHAMINE TABLETS USP, 10 mg Rx only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-09-06	HUMAN PRESCRIPTION DRUG LABEL	3
Ketorolac Tromethamine Tablets USP, 10 mg Rx only	Unit Dose Services	2023-07-26	HUMAN PRESCRIPTION DRUG LABEL	1
Ketorolac Tromethamine Tablets USP, 10 mg Rx only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
KETOROLAC TROMETHAMINE	DIRECT RX	2023-04-11	HUMAN PRESCRIPTION DRUG LABEL	6
KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only	Lake Erie Medical DBA Quality Care Products LLC	2022-08-17	HUMAN PRESCRIPTION DRUG LABEL	13910
Ketorolac Tromethamine Tablets USP, 10 mg Rx only	NuCare Pharmaceuticals,Inc.	2022-05-26	HUMAN PRESCRIPTION DRUG LABEL	1
KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	7
KETOROLAC TROMETHAMINE Tablets USP	AvKARE	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	4