Prednisone

Product NDC: 50090-1989
Requested package NDC: 50090-1989-2
11-digit product format: 500901989
Labeler code: 50090
Product ID: 50090-1989_fe03edde-9b65-4747-afba-dc1673de967e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA040392
Marketing category: ANDA
Marketing start: 2003-02-12
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 20 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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	50090-1989	50090-1989-2	D	Discontinued by firm		2026-09-14

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 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
A040392-001	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB		2003-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040392-001	AB

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`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	A040392-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040392-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040392-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040392-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040392-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040392-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040392-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040392-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040392-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040392-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040392-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040392-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040392-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040392-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040392-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040392-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040392-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040392-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040392-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040392-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040392-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040392-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040392-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040392-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040392-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040392-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040392-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040392-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040392-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040392-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040392-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040392-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040392-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040392-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040392-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040392-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040392-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040392-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040392-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040392-001	AB	1	`f41ea6bd6efb…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2205d503-be51-445b-bb34-c209cc557b3c	Product name	5	20230105
9492a99d-61c8-491f-9086-1c6a7e98c040	Product name	6	20230105
205c2cdd-a63b-cbc9-6bcb-6be6001edf81	Product name	2	20170705

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-1989-1	2023-02-07	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
50090-1989-2	2023-02-07	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
50090-1989-3	2023-02-07	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
50090-1989-5	2023-02-07	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
50090-1989-9	2023-02-07	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
50090-1989-1	2023-01-30	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
50090-1989-2	2023-01-30	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
50090-1989-3	2023-01-30	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
50090-1989-5	2023-01-30	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
50090-1989-9	2023-01-30	PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-1989-1	Prednisone	10 in 1 BOTTLE	TABLET	10	32
50090-1989-2	Prednisone	21 in 1 BOTTLE	TABLET	21	32
50090-1989-3	Prednisone	30 in 1 BOTTLE	TABLET	30	32
50090-1989-5	Prednisone	100 in 1 BOTTLE	TABLET	100	32
50090-1989-9	Prednisone	18 in 1 BOTTLE	TABLET	18	32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1989-1	EA - Each	50090-1989	9646a824-e14a-41f0-87d4-e4c3be19253e	1	2018-11-06
50090-1989-2	EA - Each	50090-1989	1eea9997-d932-4239-a1c6-b2064ad9ce22	1	2018-11-06
50090-1989-3	EA - Each	50090-1989	b1579de9-46c8-497e-aa66-75eca51fab15	1	2018-11-06
50090-1989-5	EA - Each	50090-1989	4c9db934-ecfd-4965-bec0-f4cf05f50b13	1	2018-11-06
50090-1989-9	EA - Each	50090-1989	9c4c07a2-d5ce-4ae9-ade6-20b8c731c10f	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1989	PREDNISONE TABLET [A-S MEDICATION SOLUTIONS]	30	Legacy NDC, 5 package rows	20240521_b5b088b9-8f90-468f-b7a4-a5274aa0aec9.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Par Health USA, LLC	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040392 application number: ANDA040392
Prednisone	PREDNISONE	A-S Medication Solutions	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	2026-03-19	Warnings, Adverse reactions	Exact identifier ndc (package): 50090-1989-2 ndc (product): 50090-1989 ndc11 (package): 50090198902
Prednisone	PREDNISONE	Cardinal Health 107, LLC	199ed6a6-d9d9-49de-b383-5933a026591b	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040392 application number: ANDA040392
Prednisone	PREDNISONE	American Health Packaging	a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040392 application number: ANDA040392

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VB0R961HZT	PREDNISONE	53-03-2	PREDNISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
763185	{21 (prednisone 10 MG Oral Tablet) } Pack	GPCK	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	32
198145	predniSONE 10 MG Oral Tablet	PSN	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	32
763185	predniSONE 10 MG Tablet 6 Day 21 Count Pack	PSN	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	32
312615	predniSONE 20 MG Oral Tablet	PSN	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	32
198145	prednisone 10 MG Oral Tablet	SCD	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	32
312615	prednisone 20 MG Oral Tablet	SCD	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	32
763185	Prednisone 10 MG Oral Tablet 21 Count Pack	SY	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	32

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1989-2	50090198902	21 TABLET in 1 BOTTLE (50090-1989-2)	21 tablet	2015-09-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only	A-S Medication Solutions	2026-03-19	HUMAN PRESCRIPTION DRUG LABEL	32