STRENZA

Manufacturer: Brisk Pharmaceuticals
Effective date: 2024-10-16
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 21:15:10

Label at a glance#

ProductSTRENZA

Active ingredientKETOROLAC TROMETHAMINE, PREDNISOLONE ACETATE, MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE

Label structure4 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Rx Only

NDC 73614-731-03

For Use in Eyes Only

STRENZA tm

Each Pack Contains:

Moxifloxacin Ophthalmic Solution, USP 0.5% - 3ml Bottle

Ketorolac Tromethamine Ophthalmic Solution, 0.5% - 5ml Bottle
Prednisolone Acetate Ophthalmic Suspension, USP 1% - 5ml Bottle

Brisk Pharmaceuticals

DESCRIPTION SECTION

Keep out of the reach of children.

TAMPER EVIDENT: Do not use the individual
eye drops inside the pack if the seal on its
bottle is broken or missing.

Lot: See the lot number on each individual
bottle inside the pack.
Exp: See the expiration date on each
individual bottle inside the pack.

Packaged by:
Unit Dose Solutions Inc.,
Morrisville, NC 27560
Distributed by:
Brisk pharmaceuticals,
Richardson, TX 75081

PATIENT MEDICATION INFORMATION SECTION

leaflet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	1
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	1
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	1
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	1
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	1
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	1
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	1
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	1
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
KETOROLAC Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20191108
MOXIFLOXACIN Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20230421
PREDNISOLONE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3fecff3-fb51-4f66-b443-a130905bb500	Product name	1	20250804
84b851da-be59-d750-14d1-e4d93cc3b4da	Product name	9	20250630
3a7a0034-a88d-88c3-f43e-ea34c6a216de	Product name	2	20250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659	Product name	2	20250218
6a38bd75-79e3-96c0-1204-08a0282902ae	Product name	4	20250128
4d6e22a5-3693-6edf-0179-2ab93aecbadb	Product name	9	20240724
2194a6ab-15bb-de49-cced-f09e642b1b64	Product name	8	20240313
03452e68-2506-686e-a908-f2381c778fc6	Product name	5	20240307
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5	Product name	2	20240102
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
bb41bc3a-c643-93c9-055f-a8f48f363af3	Product name	2	20190219
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553a	Product name	1	20170309
af7d3306-1338-423f-839e-419aad9e8a86	Product name	1	20170309
d7840f4c-f22a-4403-b5da-53ac6ac8fd90	Product name	1	20150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531b	Product name	2	20150611
18d57d04-4a34-a130-5dd5-b7fc47f3b567	Product name	1	20140508
379bc253-901a-e6e1-92b7-0fc574249e07	Product name	1	20140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890d	Product name	1	20140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70c	Product name	1	20140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954	Product name	1	20140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025	Product name	1	20140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6b	Product name	1	20140508
9f10552a-9a7b-8e6c-3223-dc44310af6cf	Product name	1	20140508
e44e38a9-2d9e-b0e2-cce9-490554639f3d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73614-731-03	2026-01-29	C162847	48780-1	49896155-adda-586f-e063-e6dba90add90	STRENZA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73614-731-03	STRENZA	1 in 1 CARTON	KIT	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73614-731	STRENZA (MOXIFLOXACIN 0.5%, KETOROLAC TROMETHAMINE 0.5%, PREDNISOLONE ACETATE 1%) KIT [BRISK PHARMACEUTICALS]	1	1 package rows	20241023_249b0f15-9c13-90e2-e063-6394a90a1fd5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69315-322-05	ML - Milliliter	69315-322	84a1aec3-fd5f-430c-a623-c6ee763ae3cc	1	2024-07-12
69315-322-10	ML - Milliliter	69315-322	3fce93b1-cb9a-4528-83ef-e24b082e7bd6	1	2024-07-12
61314-637-05	ML - Milliliter	61314-637	687ac068-dec0-4b7c-b191-c23c1e8fcb11	1	2012-07-24
61314-637-10	ML - Milliliter	61314-637	f2f42340-ae54-4b6a-b488-cbc294ba98a2	1	2012-07-24
61314-637-15	ML - Milliliter	61314-637	1b82c78e-4257-4c55-a503-631aebe636f3	1	2012-07-24
68180-422-01	ML - Milliliter	68180-422	e6bd441f-79e7-4e7a-9f6c-87d36199ac00	1	2017-08-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

STRENZA
Moxifloxacin 0.5%, Ketorolac Tromethamine 0.5%, Prednisolone Acetate 1%
Ketorolac Tromethamine
OCTOXYNOL-40
HYDROCHLORIC ACID
KETOROLAC
SODIUM HYDROXIDE
WATER
BENZALKONIUM CHLORIDE
EDETATE DISODIUM
SODIUM CHLORIDE
Prednisolone Acetate
POLYSORBATE 80
CITRIC ACID MONOHYDRATE
PREDNISOLONE
HYPROMELLOSE, UNSPECIFIED
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
GLYCERIN
Moxifloxacin
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
BORIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73614-731	73614-731-03
69315-322
61314-637
68180-422

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTOXYNOL-40	9T1C662FKS	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
KETOROLAC TROMETHAMINE	4EVE5946BQ	ACTIB
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
WATER	059QF0KO0R	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
PREDNISOLONE ACETATE	8B2807733D	ACTIB
EDETATE DISODIUM	7FLD91C86K	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	GR686LBA74	IACT
GLYCERIN	PDC6A3C0OX	IACT
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE	B8956S8609	ACTIM
BORIC ACID	R57ZHV85D4	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
WATER	059QF0KO0R	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 3 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202867-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2014-09-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202867-001	AT1

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202867-001	AT1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202867-001	AT1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202867-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202867-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202867-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202867-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202867-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202867-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202867-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202867-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202867-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202867-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202867-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202867-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202867-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202867-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202867-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202867-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202867-001	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202867-001	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202867-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202867-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202867-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202867-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202867-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202867-001	AT1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202867-001	AT1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202867-001	AT1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202867-001	AT1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202867-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202867-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202867-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202867-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202867-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202867-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202867-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202867-001	AT1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202867-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202867-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202867-001	AT1	1	`f41ea6bd6efb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A218204-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2024-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218204-001	AT

Observed Orange Book product history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218204-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218204-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218204-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218204-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218204-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218204-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218204-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218204-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218204-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218204-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218204-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218204-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218204-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218204-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218204-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218204-001	AT	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218204-001	AT	1	`a50c72e98297…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N017469-001	OMNIPRED	PREDNISOLONE ACETATE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017469-001	AB

Observed Orange Book product history#

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N017469-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017469-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017469-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017469-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017469-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017469-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017469-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017469-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017469-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017469-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017469-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017469-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017469-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017469-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017469-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017469-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017469-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017469-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017469-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017469-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017469-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017469-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017469-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017469-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017469-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017469-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017469-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017469-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017469-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017469-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017469-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017469-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017469-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017469-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017469-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017469-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017469-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017469-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017469-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017469-001	AB	1	`f41ea6bd6efb…`

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
Moxifloxacin	MOXIFLOXACIN	Lupin Pharmaceuticals, Inc.	ae77e219-8af9-4aa4-96d3-05c9726a1d3c	2025-10-13	Warnings, Adverse reactions	Exact identifier ndc (product): 68180-422
Prednisolone Acetate	PREDNISOLONE ACETATE	Sandoz Inc	05d205c7-8f51-46b9-a6c5-4199bc432b26	2024-12-30	Warnings, Adverse reactions	Exact identifier ndc (product): 61314-637
249b0f15-9c14-90e2-e063-6394a90a1fd5			249b0f15-9c13-90e2-e063-6394a90a1fd5	2024-10-16		Exact identifier spl id: 249b0f15-9c14-90e2-e063-6394a90a1fd5 spl set id: 249b0f15-9c13-90e2-e063-6394a90a1fd5
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Leading Pharma, LLC	c34b69c6-5cdf-41f6-8652-33bd8e9c6c70	2024-05-24	Warnings, Adverse reactions	Exact identifier ndc (product): 69315-322

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.