Prednisolone Sodium Phosphate

Product NDC: 0121-0777
11-digit product format: 001210777
Labeler code: 0121
Product ID: 0121-0777_1b34fa45-5c3c-4a81-98be-0fbe2463c3d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisolone Sodium Phosphate
Dosage form: SOLUTION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA078988
Marketing category: ANDA
Marketing start: 2017-01-31
Substance: PREDNISOLONE SODIUM PHOSPHATE
Active strength: 20 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078988-001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078988-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`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	A078988-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078988-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078988-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078988-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078988-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078988-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078988-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078988-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078988-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078988-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078988-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078988-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078988-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078988-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078988-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078988-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078988-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078988-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078988-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078988-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078988-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078988-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078988-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078988-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078988-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078988-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078988-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078988-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078988-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078988-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078988-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078988-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078988-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078988-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078988-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078988-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078988-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078988-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078988-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078988-001	AA	1	`cb3db0bc1861…`

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	20 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
702306	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
acc8badf-d9fd-4f99-a650-a149138b68b1	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
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
0121-0777-08	Prednisolone Sodium Phosphate	237 mL in 1 BOTTLE	SOLUTION	237		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0777-08	ML - Milliliter	0121-0777	d100bb21-0a54-4dfa-940e-922f1d890906	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0777	PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	8	Current NDC, Legacy NDC, 1 package rows	20250213_acc8badf-d9fd-4f99-a650-a149138b68b1.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	PAI Holdings, LLC dba PAI Pharma	acc8badf-d9fd-4f99-a650-a149138b68b1	2025-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078988 application number: ANDA078988 ndc (product): 0121-0777

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
702306	prednisoLONE sodium phosphate 20 MG in 5 mL Oral Solution	PSN	acc8badf-d9fd-4f99-a650-a149138b68b1	8
702306	prednisolone 4 MG/ML Oral Solution	SCD	acc8badf-d9fd-4f99-a650-a149138b68b1	8
702306	prednisolone 20 MG (as prednisolone sodium phosphate 26.9 MG) per 5 ML Oral Solution	SY	acc8badf-d9fd-4f99-a650-a149138b68b1	8
702306	prednisoLONE sodium phosphate 20 MG in 5 mL Oral Solution	PSN	1d247de0-f2e2-43a6-8698-1b2ea6b44260	1
702306	prednisoLONE sodium phosphate 20 MG in 5 mL Oral Solution	PSN	2162943d-15a8-49bd-8717-f728a6808e03	1
702306	prednisolone 4 MG/ML Oral Solution	SCD	1d247de0-f2e2-43a6-8698-1b2ea6b44260	1
702306	prednisolone 4 MG/ML Oral Solution	SCD	2162943d-15a8-49bd-8717-f728a6808e03	1
702306	prednisolone 20 MG (as prednisolone sodium phosphate 26.9 MG) per 5 ML Oral Solution	SY	1d247de0-f2e2-43a6-8698-1b2ea6b44260	1
702306	prednisolone 20 MG (as prednisolone sodium phosphate 26.9 MG) per 5 ML Oral Solution	SY	2162943d-15a8-49bd-8717-f728a6808e03	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-0777-08	00121077708	237 mL in 1 BOTTLE (0121-0777-08)	237 ml	2017-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (20 mg prednisolone base per 5 mL)	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2025-02-11	HUMAN PRESCRIPTION DRUG LABEL	8
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (20 mg prednisolone base per 5 mL)	PINNACLE PHARMA LLC	2021-07-08	HUMAN PRESCRIPTION DRUG LABEL	1
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (20 mg prednisolone base per 5 mL)	Medstone Pharma LLC	2021-03-08	HUMAN PRESCRIPTION DRUG LABEL	1