Prednisolone Sodium Phosphate

Product NDC: 11695-1431
11-digit product format: 116951431
Labeler code: 11695
Product ID: 11695-1431_21092699-6ba7-42d2-b148-66a669084bc6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREDNISOLONE SODIUM PHOSPHATE
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Butler Animal Health Supply
Application: ANDA040070
Marketing category: ANDA
Marketing start: 1994-07-29
Marketing end: 0000-00-00
Substance: PREDNISOLONE SODIUM PHOSPHATE
Active strength: 10 mg/mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	11695-1431		I	Inactivated by FDA		2026-09-14
excluded package	package	11695-1431	11695-1431-5	I	Inactivated by FDA		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11695-1431-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11695-1431-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11695-1431-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11695-1431-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11695-1431-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11695-1431-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11695-1431-5	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11695-1431-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11695-1431-5	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11695-1431-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11695-1431-5	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11695-1431-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11695-1431-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11695-1431-5	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11695-1431-5	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	11695-1431-5	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	11695-1431-5	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	11695-1431-5	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	11695-1431-5	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	11695-1431-5	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	11695-1431-5	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	11695-1431-5	`110d247fa046…`	`a55b01930146…`

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
A040070-001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC		RS	1994-07-29

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`f41ea6bd6efb…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3fecff3-fb51-4f66-b443-a130905bb500	Product name	1	20250804
3a7a0034-a88d-88c3-f43e-ea34c6a216de	Product name	2	20250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659	Product name	2	20250218
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5	Product name	2	20240102
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553a	Product name	1	20170309
af7d3306-1338-423f-839e-419aad9e8a86	Product name	1	20170309
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6b	Product name	1	20140508
9f10552a-9a7b-8e6c-3223-dc44310af6cf	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
e44e38a9-2d9e-b0e2-cce9-490554639f3d	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11695-1431-5	2019-10-29	C162847	48780-1	960f7f55-db86-8e05-e053-dbdaa90a074a	Prednisolone Sodium Phosphate Ophthalmic Solution USP, 1% (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11695-1431-5	Prednisolone Sodium Phosphate	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		1
11695-1431-5	Prednisolone Sodium Phosphate	1 in 1 CARTON	SOLUTION/ DROPS	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREDNISOLONE SODIUM PHOSPHATE	ACTIVE INGREDIENT	IV021NXA9J	PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BUTLER ANIMAL HEALTH SUPPLY]	1
PREDNISOLONE	ACTIVE MOIETY	9PHQ9Y1OLM	PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BUTLER ANIMAL HEALTH SUPPLY]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BUTLER ANIMAL HEALTH SUPPLY]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BUTLER ANIMAL HEALTH SUPPLY]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BUTLER ANIMAL HEALTH SUPPLY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BUTLER ANIMAL HEALTH SUPPLY]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BUTLER ANIMAL HEALTH SUPPLY]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BUTLER ANIMAL HEALTH SUPPLY]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BUTLER ANIMAL HEALTH SUPPLY]	1
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BUTLER ANIMAL HEALTH SUPPLY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BUTLER ANIMAL HEALTH SUPPLY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11695-1431	PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [BUTLER ANIMAL HEALTH SUPPLY]	1	Legacy NDC, 2 package rows	20101208_21092699-6ba7-42d2-b148-66a669084bc6.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
PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	Bausch & Lomb Incorporated	8a7f0f2a-3a48-4488-89cd-3e91c3b1365f	2023-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040070 application number: ANDA040070

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IV021NXA9J	PREDNISOLONE SODIUM PHOSPHATE	125-02-0	PREDNISOLONE SODIUM PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314165	prednisoLONE sodium phosphate 1 % Ophthalmic Solution	PSN	21092699-6ba7-42d2-b148-66a669084bc6	1
314165	prednisolone 10 MG/ML Ophthalmic Solution	SCD	21092699-6ba7-42d2-b148-66a669084bc6	1
314165	prednisolone sodium phosphate 1 % Ophthalmic Solution	SY	21092699-6ba7-42d2-b148-66a669084bc6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
11695-1431-5	11695143105	5 mL in 1 BOTTLE, DROPPER	5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prednisolone Sodium Phosphate Ophthalmic Solution USP, 1% (Sterile)	Butler Animal Health Supply \| Bausch & Lomb Incorporated	2010-11-04	HUMAN PRESCRIPTION DRUG LABEL	1