Orapred

Product NDC: 59212-700
11-digit product format: 592120700
Labeler code: 59212
Product ID: 59212-700_d172c0d5-b118-4433-92bd-05214976dd8f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prednisolone sodium phosphate
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Advanz Pharma (US) Corp.
Application: NDA021959
Marketing category: NDA
Marketing start: 2006-06-01
Substance: PREDNISOLONE SODIUM PHOSPHATE
Active strength: 10 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59212-700	59212-700-48	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021959-002	ORAPRED ODT	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021959-003	ORAPRED ODT	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021959-001	ORAPRED ODT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-01	`8072bd15b7f6…`

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: Orapred
Brand name suffix: ODT
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISOLONE SODIUM PHOSPHATE	10 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
643123	Internal RxNorm lookup
643125	Internal RxNorm lookup
643127	Internal RxNorm lookup
647127	Internal RxNorm lookup
668658	Internal RxNorm lookup
668660	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
1e379543-c4cf-4e72-953b-db15b7f0c2a1	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
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5	Product name	2	20240102
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553a	Product name	1	20170309
af7d3306-1338-423f-839e-419aad9e8a86	Product name	1	20170309
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6b	Product name	1	20140508
9f10552a-9a7b-8e6c-3223-dc44310af6cf	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	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
59212-700-06	OrapredODT	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6	12
59212-700-12	OrapredODT	2 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	2	12
59212-700-48	OrapredODT	8 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	8	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59212-700-06	EA - Each	59212-700	8a5176aa-7b1a-4800-b754-63604e117893	1	2021-03-02
59212-700-12	EA - Each	59212-700	0604f548-d49f-4f67-a5a9-d4c165362b2b	1	2021-01-08
59212-700-48	EA - Each	59212-700	52c3b564-2960-42ab-91e3-2b0ad7f76dff	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREDNISOLONE SODIUM PHOSPHATE	ACTIVE INGREDIENT	IV021NXA9J	ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]	2
PREDNISOLONE	ACTIVE MOIETY	9PHQ9Y1OLM	ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]	2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]	2
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59212-700	ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [ADVANZ PHARMA (US) CORP.]	11	Current NDC, Legacy NDC, 3 package rows	20250430_1e379543-c4cf-4e72-953b-db15b7f0c2a1.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 · 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 ndc (product): 59212-700
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

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
668658	Orapred ODT 10 MG Disintegrating Oral Tablet	PSN	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
647127	Orapred ODT 15 MG Disintegrating Oral Tablet	PSN	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
668660	Orapred ODT 30 MG Disintegrating Oral Tablet	PSN	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
643123	prednisoLONE sodium phosphate 10 MG Disintegrating Oral Tablet	PSN	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
643125	prednisoLONE sodium phosphate 15 MG Disintegrating Oral Tablet	PSN	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
643127	prednisoLONE sodium phosphate 30 MG Disintegrating Oral Tablet	PSN	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
668658	prednisolone 10 MG Disintegrating Oral Tablet [Orapred]	SBD	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
647127	prednisolone 15 MG Disintegrating Oral Tablet [Orapred]	SBD	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
668660	prednisolone 30 MG Disintegrating Oral Tablet [Orapred]	SBD	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
643123	prednisolone 10 MG Disintegrating Oral Tablet	SCD	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
643125	prednisolone 15 MG Disintegrating Oral Tablet	SCD	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
643127	prednisolone 30 MG Disintegrating Oral Tablet	SCD	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
668658	Orapred 10 MG Disintegrating Oral Tablet	SY	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
647127	Orapred 15 MG Disintegrating Oral Tablet	SY	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
668660	Orapred 30 MG Disintegrating Oral Tablet	SY	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
643123	prednisolone 10 MG (prednisolone sodium phosphate 13.4 MG) Disintegrating Oral Tablet	SY	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
643125	prednisolone 15 MG (prednisolone sodium phosphate 20.2 MG) Disintegrating Oral Tablet	SY	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12
643127	prednisolone 30 MG (as prednisolone sodium phosphate 40.3 MG) Disintegrating Oral Tablet	SY	1e379543-c4cf-4e72-953b-db15b7f0c2a1	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59212-700-06	59212070006	6 in 1 BLISTER PACK						Historical
59212-700-12	59212070012	2 BLISTER PACK in 1 CARTON (59212-700-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59212-700-06)	2 blister pack	2020-06-30	0000-00-00	No	No	Current
59212-700-48	59212070048	8 BLISTER PACK in 1 CARTON (59212-700-48) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59212-700-06)	8 blister pack	2006-06-01	0000-00-00	No	No	Current