Prednisolone Sodium Phosphate

Product NDC: 68788-7708
11-digit product format: 687887708
Labeler code: 68788
Product ID: 68788-7708_1093c0d9-480a-496c-b84d-3e9a34d74845
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisolone Sodium Phosphate
Dosage form: SOLUTION
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA076913
Marketing category: ANDA
Marketing start: 2020-06-01
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 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
A076913-001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076913-001	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 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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`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	A076913-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076913-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076913-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076913-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076913-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076913-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076913-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076913-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076913-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076913-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076913-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076913-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076913-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076913-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076913-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076913-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076913-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076913-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076913-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076913-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076913-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076913-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076913-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076913-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076913-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076913-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076913-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076913-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076913-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076913-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076913-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076913-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076913-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076913-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076913-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076913-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076913-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076913-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076913-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076913-001	AA	1	`f41ea6bd6efb…`

Additional Listing Data#

Finished product: Yes
Brand name base: Prednisolone Sodium Phosphate
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283077	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
93b372f7-b811-4c15-85c4-c6dbac342cb4	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
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
68788-7708-2	Prednisolone Sodium Phosphate	237 mL in 1 BOTTLE	SOLUTION	237		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7708-2	ML - Milliliter	68788-7708	03d277d2-f878-4b04-80a4-df6060174c76	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7708	PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240802_93b372f7-b811-4c15-85c4-c6dbac342cb4.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Preferred Pharmaceuticals, Inc.	93b372f7-b811-4c15-85c4-c6dbac342cb4	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076913 application number: ANDA076913 ndc (product): 68788-7708
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	REMEDYREPACK INC.	f87ce1ba-335e-463d-87d5-9af0206f8f61	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076913 application number: ANDA076913
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	a0d74ae0-7b2d-4d36-9211-c76f5063b5a9	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076913 application number: ANDA076913
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	A-S Medication Solutions	4c507319-8add-4952-8bea-ff77ab17088f	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076913 application number: ANDA076913
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Proficient Rx LP	14b7f41b-4df1-42cb-bd1b-c74b28de2670	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076913 application number: ANDA076913

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
283077	prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution	PSN	93b372f7-b811-4c15-85c4-c6dbac342cb4	6
283077	prednisolone 3 MG/ML Oral Solution	SCD	93b372f7-b811-4c15-85c4-c6dbac342cb4	6
283077	prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution	SY	93b372f7-b811-4c15-85c4-c6dbac342cb4	6
283077	prednisolone 15 MG per 5 ML Oral Solution	SY	93b372f7-b811-4c15-85c4-c6dbac342cb4	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7708-2	68788770802	237 mL in 1 BOTTLE (68788-7708-2)	237 ml	2020-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (15 mg Prednisolone Base per 5 mL)	Preferred Pharmaceuticals, Inc.	2026-08-18	HUMAN PRESCRIPTION DRUG LABEL	7