Prednisolone Acetate

Product NDC: 61314-637
11-digit product format: 613140637
Labeler code: 61314
Product ID: 61314-637_32f12438-f75f-459e-a41f-34dcc8a9e4f7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisolone Acetate
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: NDA017469
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1994-12-15
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 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
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#

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 · 41 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
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	N017469-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017469-001	AB	1	`cb3db0bc1861…`

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
05d205c7-8f51-46b9-a6c5-4199bc432b26	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
e42b5738-f3b2-36cb-547c-d658794618bc	Product name	2	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
4ce8f27b-067c-45ad-b8f6-4b29ec66e497	Product name	2	20250115
b81a1117-443d-49e4-a709-58c3c32468af	Product name	5	20241010
4d6e22a5-3693-6edf-0179-2ab93aecbadb	Product name	9	20240724
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
ee6f8cae-1597-1a7e-3fb9-6aaeba954efe	Product name	3	20150902
d7840f4c-f22a-4403-b5da-53ac6ac8fd90	Product name	1	20150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531b	Product name	2	20150611
8442aba0-7521-47cb-8a4e-c9896f35e8ae	Product name	3	20150317
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61314-637-05	Prednisolone Acetate	5 mL in 1 BOTTLE, PLASTIC	SUSPENSION/ DROPS	5	7
61314-637-05	Prednisolone Acetate	1 in 1 CARTON	SUSPENSION/ DROPS	1	7
61314-637-10	Prednisolone Acetate	1 in 1 CARTON	SUSPENSION/ DROPS	1	7
61314-637-10	Prednisolone Acetate	10 mL in 1 BOTTLE, PLASTIC	SUSPENSION/ DROPS	10	7
61314-637-15	Prednisolone Acetate	1 in 1 CARTON	SUSPENSION/ DROPS	1	7
61314-637-15	Prednisolone Acetate	15 mL in 1 BOTTLE, PLASTIC	SUSPENSION/ DROPS	15	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREDNISOLONE ACETATE	ACTIVE INGREDIENT	8B2807733D	PREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]	2
PREDNISOLONE ACETATE	ACTIVE INGREDIENT	8B2807733D	PREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
PREDNISOLONE	ACTIVE MOIETY	9PHQ9Y1OLM	PREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]	2
PREDNISOLONE	ACTIVE MOIETY	9PHQ9Y1OLM	PREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	PREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	PREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	PREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	PREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREDNISOLONE ACETATE SUSPENSION [FALCON PHARMACEUTICALS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREDNISOLONE ACETATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61314-637	PREDNISOLONE ACETATE SUSPENSION/ DROPS [SANDOZ INC]	7	Current NDC, Legacy NDC, 6 package rows	20250108_05d205c7-8f51-46b9-a6c5-4199bc432b26.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisolone Acetate	PREDNISOLONE ACETATE	Sportpharm LLC	3011a244-24a4-46ef-979a-b5d9e7076246	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017469 application number: NDA017469
Prednisolone Acetate	PREDNISOLONE ACETATE	Sandoz Inc	05d205c7-8f51-46b9-a6c5-4199bc432b26	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017469 application number: NDA017469 ndc (product): 61314-637
Prednisolone Acetate	PREDNISOLONE ACETATE	A-S Medication Solutions	b1d30a4f-4941-45a5-bd24-fea07f1bfc87	2023-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017469 application number: NDA017469

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	b1d30a4f-4941-45a5-bd24-fea07f1bfc87	14
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	b1d30a4f-4941-45a5-bd24-fea07f1bfc87	14
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	b1d30a4f-4941-45a5-bd24-fea07f1bfc87	14
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	48d8fd35-51e7-4592-b901-46dd7e8e32b8	9
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	48d8fd35-51e7-4592-b901-46dd7e8e32b8	9
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	48d8fd35-51e7-4592-b901-46dd7e8e32b8	9
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	05d205c7-8f51-46b9-a6c5-4199bc432b26	7
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	05d205c7-8f51-46b9-a6c5-4199bc432b26	7
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	05d205c7-8f51-46b9-a6c5-4199bc432b26	7
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	b17d2a0e-5f89-4253-9a8a-bb6ec59919fe	2
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	b17d2a0e-5f89-4253-9a8a-bb6ec59919fe	2
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	b17d2a0e-5f89-4253-9a8a-bb6ec59919fe	2
578018	bromfenac 0.09 % Ophthalmic Solution	PSN	2df9064c-0527-4c21-e063-6294a90a56d8	1
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	2df9064c-0527-4c21-e063-6294a90a56d8	1
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	96232353-7a98-374d-e053-2a95a90a0569	1
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	1fbfceac-51ba-5d82-e063-6394a90a71ee	1
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	2df9064c-0527-4c21-e063-6294a90a56d8	1
578018	bromfenac 0.9 MG/ML Ophthalmic Solution	SCD	2df9064c-0527-4c21-e063-6294a90a56d8	1
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	2df9064c-0527-4c21-e063-6294a90a56d8	1
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	2df9064c-0527-4c21-e063-6294a90a56d8	1
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	96232353-7a98-374d-e053-2a95a90a0569	1
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	1fbfceac-51ba-5d82-e063-6394a90a71ee	1
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
578018	bromfenac 0.09 % Ophthalmic Solution	SY	2df9064c-0527-4c21-e063-6294a90a56d8	1
578018	bromfenac 0.9 MG/ML (bromfenac sodium 1.035 MG/ML) Ophthalmic Solution	SY	2df9064c-0527-4c21-e063-6294a90a56d8	1
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	2df9064c-0527-4c21-e063-6294a90a56d8	1
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	2df9064c-0527-4c21-e063-6294a90a56d8	1
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	1fbfceac-51ba-5d82-e063-6394a90a71ee	1
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	96232353-7a98-374d-e053-2a95a90a0569	1
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	249b0f15-9c13-90e2-e063-6394a90a1fd5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61314-637-05	61314063705	1 BOTTLE, PLASTIC in 1 CARTON (61314-637-05) / 5 mL in 1 BOTTLE, PLASTIC	1994-12-15	0000-00-00	No	No	Current
61314-637-10	61314063710	1 BOTTLE, PLASTIC in 1 CARTON (61314-637-10) / 10 mL in 1 BOTTLE, PLASTIC	1994-12-15	0000-00-00	No	No	Current
61314-637-15	61314063715	1 BOTTLE, PLASTIC in 1 CARTON (61314-637-15) / 15 mL in 1 BOTTLE, PLASTIC	1994-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prednisolone Acetate Ophthalmic Suspension, USP, 1%	Sportpharm LLC	2026-07-23	HUMAN PRESCRIPTION DRUG LABEL	1
STRENZA PLUS	Brisk Pharmaceuticals	2025-02-12	HUMAN PRESCRIPTION DRUG LABEL	1
Prednisolone Acetate Ophthalmic Suspension, USP, 1%	Sandoz Inc	2024-12-30	HUMAN PRESCRIPTION DRUG LABEL	7
STRENZA	Brisk Pharmaceuticals	2024-10-16	HUMAN PRESCRIPTION DRUG LABEL	1
Prednisolone Acetate Ophthalmic Suspension, USP, 1%	RedPharm Drug	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	1
Prednisolone Acetate Ophthalmic Suspension, USP, 1%	REMEDYREPACK INC.	2024-02-02	HUMAN PRESCRIPTION DRUG LABEL	1
Prednisolone Acetate Ophthalmic Suspension, USP, 1%	A-S Medication Solutions	2023-04-30	HUMAN PRESCRIPTION DRUG LABEL	14
Prednisolone Acetate Ophthalmic Suspension USP, 1%	A-S Medication Solutions	2020-07-13	HUMAN PRESCRIPTION DRUG LABEL	9
PREDNISOLONE ACETATE	DIRECT RX	2019-10-30	HUMAN PRESCRIPTION DRUG LABEL	1
Prednisolone Acetate Ophthalmic Suspension USP, 1%	Physicians Total Care, Inc.	2012-10-23	HUMAN PRESCRIPTION DRUG LABEL	2