prednisolone sodium phosphate

Product NDC: 50742-384
11-digit product format: 507420384
Labeler code: 50742
Product ID: 50742-384_ebbc1751-9381-4db1-89ff-ae5a2963fb2c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prednisolone sodium phosphate
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Ingenus Pharmaceuticals, LLC
Application: NDA021959
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2025-09-15
Substance: PREDNISOLONE SODIUM PHOSPHATE
Active strength: 15 mg/1
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021959-001	ORAPRED ODT	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01
N021959-002	ORAPRED ODT	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01
N021959-003	ORAPRED ODT	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021959-002	ORAPRED ODT	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021959-003	ORAPRED ODT	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021959-002	ORAPRED ODT	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021959-003	ORAPRED ODT	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021959-002	ORAPRED ODT	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021959-003	ORAPRED ODT	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021959-002	ORAPRED ODT	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021959-003	ORAPRED ODT	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021959-002	ORAPRED ODT	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021959-003	ORAPRED ODT	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021959-002	ORAPRED ODT	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021959-003	ORAPRED ODT	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021959-002	ORAPRED ODT	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021959-003	ORAPRED ODT	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021959-002	ORAPRED ODT	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021959-003	ORAPRED ODT	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021959-002	ORAPRED ODT	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021959-003	ORAPRED ODT	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021959-002	ORAPRED ODT	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021959-003	ORAPRED ODT	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021959-002	ORAPRED ODT	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021959-003	ORAPRED ODT	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021959-002	ORAPRED ODT	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021959-003	ORAPRED ODT	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021959-002	ORAPRED ODT	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021959-003	ORAPRED ODT	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021959-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021959-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021959-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021959-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021959-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021959-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021959-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021959-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021959-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021959-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021959-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021959-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021959-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021959-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021959-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021959-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021959-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021959-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021959-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021959-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021959-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021959-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021959-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021959-003	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021959-001	6740341	2019-11-24	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021959-002	6740341	2019-11-24	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021959-003	6740341	2019-11-24	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021959-001	6740341	2019-11-24	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021959-002	6740341	2019-11-24	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021959-003	6740341	2019-11-24	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021959-001	6740341	2019-11-24	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021959-002	6740341	2019-11-24	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021959-003	6740341	2019-11-24	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021959-001	6740341	2019-11-24	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021959-002	6740341	2019-11-24	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021959-003	6740341	2019-11-24	Drug product	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: prednisolone sodium phosphate
Brand name suffix: ODT
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISOLONE SODIUM PHOSPHATE	15 mg/1

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
643123	Internal RxNorm lookup
643125	Internal RxNorm lookup
643127	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
ebbc1751-9381-4db1-89ff-ae5a2963fb2c	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
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
50742-384-06	prednisolone sodium phosphateODT	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6		1
50742-384-12	prednisolone sodium phosphateODT	2 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	2		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50742-384-06	EA - Each	50742-384	0eb185ff-5a0d-44f6-bca6-46d8458e575b	1	2025-11-13
50742-384-12	EA - Each	50742-384	0b2ee699-b417-40cf-8e8d-e1ed8611ee39	1	2025-11-13

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orapred ODT	PREDNISOLONE SODIUM PHOSPHATE	Advanz Pharma (US) Corp.	1e379543-c4cf-4e72-953b-db15b7f0c2a1	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021959 application number: NDA021959
prednisolone sodium phosphate ODT	PREDNISOLONE SODIUM PHOSPHATE	Ingenus Pharmaceuticals, LLC	ebbc1751-9381-4db1-89ff-ae5a2963fb2c	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021959 application number: NDA021959 ndc (product): 50742-384

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
643123	prednisoLONE sodium phosphate 10 MG Disintegrating Oral Tablet	PSN	ebbc1751-9381-4db1-89ff-ae5a2963fb2c	1
643125	prednisoLONE sodium phosphate 15 MG Disintegrating Oral Tablet	PSN	ebbc1751-9381-4db1-89ff-ae5a2963fb2c	1
643127	prednisoLONE sodium phosphate 30 MG Disintegrating Oral Tablet	PSN	ebbc1751-9381-4db1-89ff-ae5a2963fb2c	1
643123	prednisolone 10 MG Disintegrating Oral Tablet	SCD	ebbc1751-9381-4db1-89ff-ae5a2963fb2c	1
643125	prednisolone 15 MG Disintegrating Oral Tablet	SCD	ebbc1751-9381-4db1-89ff-ae5a2963fb2c	1
643127	prednisolone 30 MG Disintegrating Oral Tablet	SCD	ebbc1751-9381-4db1-89ff-ae5a2963fb2c	1
643123	prednisolone 10 MG (prednisolone sodium phosphate 13.4 MG) Disintegrating Oral Tablet	SY	ebbc1751-9381-4db1-89ff-ae5a2963fb2c	1
643125	prednisolone 15 MG (prednisolone sodium phosphate 20.2 MG) Disintegrating Oral Tablet	SY	ebbc1751-9381-4db1-89ff-ae5a2963fb2c	1
643127	prednisolone 30 MG (as prednisolone sodium phosphate 40.3 MG) Disintegrating Oral Tablet	SY	ebbc1751-9381-4db1-89ff-ae5a2963fb2c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50742-384-06	50742038406	6 in 1 BLISTER PACK					Historical
50742-384-12	50742038412	2 BLISTER PACK in 1 CARTON (50742-384-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50742-384-06)	2 blister pack	2025-09-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
prednisolone sodium phosphate ODT	Ingenus Pharmaceuticals, LLC	2024-04-18	Human Prescription Drug Label	1