PREDNISOLONE ACETATE

Product NDC: 60758-119
11-digit product format: 607580119
Labeler code: 60758
Product ID: 60758-119_9bb24539-c1ac-4ce6-88a8-a5dfad588c27
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prednisolone acetate
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Pacific Pharma, Inc.
Application: NDA017011
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1997-08-19
Substance: PREDNISOLONE ACETATE
Active strength: 10 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 42.

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
N017011-001	PRED FORTE	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
N017011-001	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.

Product history page 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N017011-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017011-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017011-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017011-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017011-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017011-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017011-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017011-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017011-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017011-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017011-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017011-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017011-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017011-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017011-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017011-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017011-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017011-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017011-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017011-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017011-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017011-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017011-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017011-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017011-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017011-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017011-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017011-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017011-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017011-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017011-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017011-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017011-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017011-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017011-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017011-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017011-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017011-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017011-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017011-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: PREDNISOLONE ACETATE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISOLONE ACETATE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8B2807733D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1376336	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
1474d1df-70b6-4b1e-86d1-3349aa6d42fb	Available on FDA.report

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
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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
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
bb41bc3a-c643-93c9-055f-a8f48f363af3	Product name	2	20190219
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
d7840f4c-f22a-4403-b5da-53ac6ac8fd90	Product name	1	20150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531b	Product name	2	20150611
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
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70c	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
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60758-119-05	PREDNISOLONE ACETATE	1 in 1 CARTON	SUSPENSION/ DROPS	1	11
60758-119-05	PREDNISOLONE ACETATE	5 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	5	11
60758-119-10	PREDNISOLONE ACETATE	10 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	10	11
60758-119-10	PREDNISOLONE ACETATE	1 in 1 CARTON	SUSPENSION/ DROPS	1	11
60758-119-15	PREDNISOLONE ACETATE	15 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	15	11
60758-119-15	PREDNISOLONE ACETATE	1 in 1 CARTON	SUSPENSION/ DROPS	1	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60758-119-05	ML - Milliliter	60758-119	0583cff3-db8a-4969-82eb-c9947fd1ba41	1	2012-07-24
60758-119-10	ML - Milliliter	60758-119	3e1bf846-dac5-439d-b5a3-be6d4a18c717	1	2012-07-24
60758-119-15	ML - Milliliter	60758-119	5377df34-3004-4e14-8fcd-1b41cca86920	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
prednisolone acetate	ACTIVE INGREDIENT	8B2807733D	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
prednisolone acetate	ACTIVE INGREDIENT	8B2807733D	PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]	3
prednisolone	ACTIVE MOIETY	9PHQ9Y1OLM	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
prednisolone	ACTIVE MOIETY	9PHQ9Y1OLM	PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]	3
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]	3
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]	3
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]	3
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]	3
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]	3
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
sodium bisulfite	INACTIVE INGREDIENT	TZX5469Z6I	PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]	3
sodium bisulfite	INACTIVE INGREDIENT	TZX5469Z6I	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]	3
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]	3
water	INACTIVE INGREDIENT	059QF0KO0R	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
water	INACTIVE INGREDIENT	059QF0KO0R	PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60758-119	PREDNISOLONE ACETATE SUSPENSION/ DROPS [PACIFIC PHARMA, INC.]	10	Current NDC, Legacy NDC, 6 package rows	20240405_1474d1df-70b6-4b1e-86d1-3349aa6d42fb.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	A-S Medication Solutions	dd32d625-fb2f-4c51-89fe-cdccdf0201b9	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Sportpharm LLC	02fc6f0b-d053-49e1-82de-f272dd05d529	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	A-S Medication Solutions	388abc87-cd5a-4e88-8675-7bf0c5ce7af5	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	NuCare Pharmaceuticals,Inc.	ab72cf3d-7660-41b1-e053-2995a90a7f44	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Pacific Pharma, Inc.	1474d1df-70b6-4b1e-86d1-3349aa6d42fb	2024-03-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011 ndc (product): 60758-119
PRED FORTE	PREDNISOLONE ACETATE	Allergan, Inc.	00a5aa88-e361-4ea7-8922-530c738b726e	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Asclemed USA, Inc.	232e40a5-17c5-4cf3-9e3b-110a194ad4be	2021-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8B2807733D	PREDNISOLONE ACETATE	52-21-1	PREDNISOLONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	1474d1df-70b6-4b1e-86d1-3349aa6d42fb	11
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	1474d1df-70b6-4b1e-86d1-3349aa6d42fb	11
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	1474d1df-70b6-4b1e-86d1-3349aa6d42fb	11
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	388abc87-cd5a-4e88-8675-7bf0c5ce7af5	8
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	388abc87-cd5a-4e88-8675-7bf0c5ce7af5	8
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	388abc87-cd5a-4e88-8675-7bf0c5ce7af5	8
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	dd32d625-fb2f-4c51-89fe-cdccdf0201b9	5
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	dd32d625-fb2f-4c51-89fe-cdccdf0201b9	5
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	dd32d625-fb2f-4c51-89fe-cdccdf0201b9	5
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	c77597c4-8add-4d2a-b8c1-e526cbe22dcb	3
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	ab72cf3d-7660-41b1-e053-2995a90a7f44	3
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	c77597c4-8add-4d2a-b8c1-e526cbe22dcb	3
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	ab72cf3d-7660-41b1-e053-2995a90a7f44	3
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	ab72cf3d-7660-41b1-e053-2995a90a7f44	3
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	c77597c4-8add-4d2a-b8c1-e526cbe22dcb	3
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	02fc6f0b-d053-49e1-82de-f272dd05d529	2
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	02fc6f0b-d053-49e1-82de-f272dd05d529	2
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	02fc6f0b-d053-49e1-82de-f272dd05d529	2
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	1cfb4f31-b1d9-2287-e063-6394a90a9a4d	1
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	232e40a5-17c5-4cf3-9e3b-110a194ad4be	1
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	1cfb4f31-b1d9-2287-e063-6394a90a9a4d	1
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	232e40a5-17c5-4cf3-9e3b-110a194ad4be	1
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	232e40a5-17c5-4cf3-9e3b-110a194ad4be	1
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	1cfb4f31-b1d9-2287-e063-6394a90a9a4d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60758-119-05	60758011905	1 BOTTLE, DROPPER in 1 CARTON (60758-119-05) / 5 mL in 1 BOTTLE, DROPPER	1997-08-19	0000-00-00	No	No	Current
60758-119-10	60758011910	1 BOTTLE, DROPPER in 1 CARTON (60758-119-10) / 10 mL in 1 BOTTLE, DROPPER	1997-08-19	0000-00-00	No	No	Current
60758-119-15	60758011915	1 BOTTLE, DROPPER in 1 CARTON (60758-119-15) / 15 mL in 1 BOTTLE, DROPPER	1997-08-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREDNISOLONE ACETATE ophthalmic suspension, USP 1% sterile	A-S Medication Solutions	2026-08-03	HUMAN PRESCRIPTION DRUG LABEL	7
PREDNISOLONE ACETATE ophthalmic suspension, USP 1% sterile	Sportpharm LLC	2026-04-24	HUMAN PRESCRIPTION DRUG LABEL	2
PREDNISOLONE ACETATE ophthalmic suspension, USP 1% sterile	A-S Medication Solutions	2024-10-14	HUMAN PRESCRIPTION DRUG LABEL	8
PREDNISOLONE ACETATE ophthalmic suspension, USP 1% sterile	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	3
PREDNISOLONE ACETATE ophthalmic suspension, USP 1% sterile	RedPharm Drug	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL	1
PREDNISOLONE ACETATE ophthalmic suspension, USP 1% sterile	Pacific Pharma, Inc.	2024-03-19	HUMAN PRESCRIPTION DRUG LABEL	11
PREDNISOLONE ACETATE ophthalmic suspension, USP 1% sterile	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2021-11-30	HUMAN PRESCRIPTION DRUG LABEL	1
IXOBA M	Brisk Pharmaceuticals, Inc. \| Unit Dose Solutions, Inc	2021-11-03	HUMAN PRESCRIPTION DRUG LABEL	2
PREDNISOLONE ACETATE ophthalmic suspension, USP 1%	NuCare Pharmaceuticals,Inc.	2017-07-18	HUMAN PRESCRIPTION DRUG LABEL	1
PREDNISOLONE ACETATE ophthalmic suspension, USP 1.0%	H.J. Harkins Company, Inc. \| Pacific Pharma, Inc.	2011-11-17	HUMAN PRESCRIPTION DRUG LABEL	3