Prednisolone Sodium Phosphate

Product NDC: 42799-815
Requested package NDC: 42799-815-01
11-digit product format: 427990815
Labeler code: 42799
Product ID: 42799-815_462f70d9-438c-e6b2-e063-6394a90a1bbb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisolone Sodium Phosphate
Dosage form: SOLUTION
Route: ORAL
Labeler: Edenbridge Pharmaceuticals LLC.
Application: ANDA203559
Marketing category: ANDA
Marketing start: 2023-10-09
Substance: PREDNISOLONE SODIUM PHOSPHATE
Active strength: 15 mg/5mL
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203559-001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20
A203559-002	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20
A203559-003	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06
A203559-004	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A203559-001	AA
A203559-002	AA
A203559-003	AA
A203559-004	AA

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 4 · 128 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
2026-02-19 14:30 UTC	2026-02	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 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	A203559-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203559-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203559-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203559-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203559-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203559-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203559-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203559-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203559-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203559-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203559-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203559-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203559-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203559-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203559-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203559-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203559-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203559-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203559-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203559-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203559-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203559-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203559-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203559-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203559-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203559-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203559-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203559-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203559-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203559-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203559-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203559-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203559-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203559-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203559-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203559-004	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203559-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203559-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203559-003	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203559-004	AA	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Prednisolone Sodium Phosphate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISOLONE SODIUM PHOSPHATE	15 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IV021NXA9J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
249066	Internal RxNorm lookup
283077	Internal RxNorm lookup
702306	Internal RxNorm lookup
794979	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
1793e218-7b49-497d-879f-1020de6e6d68	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
3a7a0034-a88d-88c3-f43e-ea34c6a216de	Product name	2	20250311
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
9dbc4744-f7be-4393-b71a-e1bfd8b97659	Product name	2	20250218
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5	Product name	2	20240102
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553a	Product name	1	20170309
af7d3306-1338-423f-839e-419aad9e8a86	Product name	1	20170309
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
73adedd8-aba8-27d9-78d9-2e3c4a3cf954	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	Strength	SPL version
42799-815-01	Prednisolone Sodium Phosphate	237 mL in 1 BOTTLE, PLASTIC	SOLUTION	237		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42799-815-01	ML - Milliliter	42799-815	f614fff2-3277-4b14-8006-c2b35bb9e747	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42799-815	PREDNISOLONE SODIUM PHOSPHATE SOLUTION [EDENBRIDGE PHARMACEUTICALS LLC.]	12	Current NDC, 1 package rows	20250129_1793e218-7b49-497d-879f-1020de6e6d68.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	ATLANTIC BIOLOGICALS CORP.	96de9cad-2fb7-4947-87ae-4db57563a83a	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203559 application number: ANDA203559
prednisoLONE sodium phosphate	PREDNISOLONE SODIUM PHOSPHATE	Kesin Pharma	4c0dcbfd-2848-9bd0-e063-6394a90af5a7	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203559 application number: ANDA203559
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Redpharm Drug	3253b63b-0533-6cdc-e063-6294a90aa311	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203559 application number: ANDA203559
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Edenbridge Pharmaceuticals LLC.	1793e218-7b49-497d-879f-1020de6e6d68	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203559 application number: ANDA203559 ndc (package): 42799-815-01 ndc (product): 42799-815 ndc11 (package): 42799081501
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Preferred Pharmaceuticals Inc.	7262fc84-3db2-4475-8ae4-6bec4477cb81	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203559 application number: ANDA203559
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Atlantic Biologicals Corp	401f7ba6-a4a2-9ae6-e063-6394a90a4210	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203559 application number: ANDA203559

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
794979	prednisoLONE sodium phosphate 10 MG in 5 mL Oral Solution	PSN	1793e218-7b49-497d-879f-1020de6e6d68	14
283077	prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution	PSN	1793e218-7b49-497d-879f-1020de6e6d68	14
702306	prednisoLONE sodium phosphate 20 MG in 5 mL Oral Solution	PSN	1793e218-7b49-497d-879f-1020de6e6d68	14
249066	prednisoLONE sodium phosphate 25 MG in 5 mL Oral Solution	PSN	1793e218-7b49-497d-879f-1020de6e6d68	14
794979	prednisolone 2 MG/ML Oral Solution	SCD	1793e218-7b49-497d-879f-1020de6e6d68	14
283077	prednisolone 3 MG/ML Oral Solution	SCD	1793e218-7b49-497d-879f-1020de6e6d68	14
702306	prednisolone 4 MG/ML Oral Solution	SCD	1793e218-7b49-497d-879f-1020de6e6d68	14
249066	prednisolone 5 MG/ML Oral Solution	SCD	1793e218-7b49-497d-879f-1020de6e6d68	14
794979	prednisolone 10 MG per 5 ML Oral Solution	SY	1793e218-7b49-497d-879f-1020de6e6d68	14
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	1793e218-7b49-497d-879f-1020de6e6d68	14
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	1793e218-7b49-497d-879f-1020de6e6d68	14
702306	prednisolone 20 MG (as prednisolone sodium phosphate 26.9 MG) per 5 ML Oral Solution	SY	1793e218-7b49-497d-879f-1020de6e6d68	14
249066	prednisolone 25 MG (prednisolone sodium phosphate 33.6 MG) per 5 ML Oral Solution	SY	1793e218-7b49-497d-879f-1020de6e6d68	14
283077	prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution	PSN	3253b63b-0533-6cdc-e063-6294a90aa311	4
283077	prednisolone 3 MG/ML Oral Solution	SCD	3253b63b-0533-6cdc-e063-6294a90aa311	4
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	3253b63b-0533-6cdc-e063-6294a90aa311	4
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	3253b63b-0533-6cdc-e063-6294a90aa311	4
283077	prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution	PSN	96de9cad-2fb7-4947-87ae-4db57563a83a	2
283077	prednisolone 3 MG/ML Oral Solution	SCD	96de9cad-2fb7-4947-87ae-4db57563a83a	2
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	96de9cad-2fb7-4947-87ae-4db57563a83a	2
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	96de9cad-2fb7-4947-87ae-4db57563a83a	2
283077	prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution	PSN	401f7ba6-a4a2-9ae6-e063-6394a90a4210	1
283077	prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution	PSN	7262fc84-3db2-4475-8ae4-6bec4477cb81	1
283077	prednisolone 3 MG/ML Oral Solution	SCD	401f7ba6-a4a2-9ae6-e063-6394a90a4210	1
283077	prednisolone 3 MG/ML Oral Solution	SCD	7262fc84-3db2-4475-8ae4-6bec4477cb81	1
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	401f7ba6-a4a2-9ae6-e063-6394a90a4210	1
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	7262fc84-3db2-4475-8ae4-6bec4477cb81	1
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	401f7ba6-a4a2-9ae6-e063-6394a90a4210	1
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	7262fc84-3db2-4475-8ae4-6bec4477cb81	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42799-815-01	42799081501	237 mL in 1 BOTTLE, PLASTIC (42799-815-01)	237 ml	2023-10-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prednisolone Sodium Phosphate Oral Solution	ATLANTIC BIOLOGICALS CORP.	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	3
Prednisolone Sodium Phosphate Oral Solution	Redpharm Drug	2025-12-24	HUMAN PRESCRIPTION DRUG LABEL	4
Prednisolone Sodium Phosphate Oral Solution	Edenbridge Pharmaceuticals LLC.	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL	14
Prednisolone Sodium Phosphate Oral Solution	Preferred Pharmaceuticals Inc.	2025-10-28	HUMAN PRESCRIPTION DRUG LABEL	1
Prednisolone Sodium Phosphate Oral Solution	Atlantic Biologicals Corp	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	1