Prednisone

Product NDC: 50090-7024
11-digit product format: 500907024
Labeler code: 50090
Product ID: 50090-7024_a94e9e6b-45f2-4e67-aef0-bf0256e10406
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA040256
Marketing category: ANDA
Marketing start: 2002-07-12
Substance: PREDNISONE
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040256-001	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB		2002-07-12
A040256-002	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB		2002-07-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040256-001	AB
A040256-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040256-001	PREDNISONE	5MG	TABLET / ORAL	AB	2002-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040256-002	PREDNISONE	10MG	TABLET / ORAL	AB	2002-07-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040256-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040256-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040256-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040256-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040256-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040256-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040256-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040256-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040256-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040256-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040256-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040256-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040256-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040256-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040256-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040256-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040256-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040256-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040256-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040256-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040256-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040256-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040256-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040256-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040256-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040256-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040256-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040256-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040256-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040256-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040256-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040256-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040256-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040256-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040256-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040256-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040256-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040256-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040256-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040256-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Prednisone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISONE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VB0R961HZT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198145	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
44069d49-4cf4-4f1e-9fbd-b496c6ca81a1	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-7024-0	Prednisone	10 in 1 BOTTLE	TABLET	10	1
50090-7024-1	Prednisone	15 in 1 BOTTLE	TABLET	15	1
50090-7024-2	Prednisone	21 in 1 BOTTLE	TABLET	21	1
50090-7024-4	Prednisone	50 in 1 BOTTLE	TABLET	50	1
50090-7024-5	Prednisone	30 in 1 BOTTLE	TABLET	30	1
50090-7024-8	Prednisone	40 in 1 BOTTLE	TABLET	40	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7024-0	EA - Each	50090-7024	f10500dc-9406-45c9-96ed-c6ccff5a8684	1	2025-01-14
50090-7024-1	EA - Each	50090-7024	e3923e06-9540-40e0-be2c-98a4fcd1995d	1	2025-01-14
50090-7024-2	EA - Each	50090-7024	bdc12221-4ec8-47bb-83e5-0aa7ab4dc523	1	2025-01-14
50090-7024-4	EA - Each	50090-7024	05be16ca-63a5-4772-ba9e-324b0f5dda53	1	2025-01-14
50090-7024-5	EA - Each	50090-7024	91e40a6d-9882-46e1-90fe-93ed7b163246	1	2025-01-14
50090-7024-8	EA - Each	50090-7024	08e42d00-4eae-4ea2-80d8-ac8058fa9794	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-7024	PREDNISONE TABLET [A-S MEDICATION SOLUTIONS]	1	Current NDC, 6 package rows	20240119_44069d49-4cf4-4f1e-9fbd-b496c6ca81a1.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	REMEDYREPACK INC.	746b0bcd-122e-4ea8-a824-28415073a38e	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Preferred Pharmaceuticals, Inc.	f89bd1dc-88cd-4aef-a7ae-6310f38a3423	2026-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Cardinal Health 107, LLC	568b8880-7997-4786-8c57-28816ce52655	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Par Health USA, LLC	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Bryant Ranch Prepack	931171e2-0bdb-451e-b737-72ce3ffbed53	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Bryant Ranch Prepack	55aedced-d945-4bd2-9aa8-0f18b89a0e7f	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Bryant Ranch Prepack	290a91e5-22ae-4d62-ab34-39a3117002e2	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Major Pharmaceuticals	57b98930-92ab-4b77-a033-ae9895ee718a	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	A-S Medication Solutions	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	A-S Medication Solutions	71295010-5adb-499b-a03a-5c78b5e79b2d	2026-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Cardinal Health 107, LLC	199ed6a6-d9d9-49de-b383-5933a026591b	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	A-S Medication Solutions	efe0c82b-9dd9-4729-b06f-06307867aca0	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	American Health Packaging	a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	A-S Medication Solutions	95cf05e5-1446-43f5-8447-c04877a74781	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	A-S Medication Solutions	410988ea-456a-454e-932c-fcbdbef04ba9	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	A-S Medication Solutions	44069d49-4cf4-4f1e-9fbd-b496c6ca81a1	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256 ndc (product): 50090-7024
Prednisone	PREDNISONE	Proficient Rx LP	7d52bf53-76e3-4826-a12b-b16a8560bafc	2021-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256
Prednisone	PREDNISONE	Aphena Pharma Solutions - Tennessee, LLC	b902ed21-c776-4046-8fbc-9ce95b16b139	2017-12-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040256 application number: ANDA040256

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
198145	predniSONE 10 MG Oral Tablet	PSN	44069d49-4cf4-4f1e-9fbd-b496c6ca81a1	1
198145	prednisone 10 MG Oral Tablet	SCD	44069d49-4cf4-4f1e-9fbd-b496c6ca81a1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-7024-0	50090702400	10 TABLET in 1 BOTTLE (50090-7024-0)	10 tablet	2024-01-08	No	No	Current
50090-7024-1	50090702401	15 TABLET in 1 BOTTLE (50090-7024-1)	15 tablet	2024-01-08	No	No	Current
50090-7024-2	50090702402	21 TABLET in 1 BOTTLE (50090-7024-2)	21 tablet	2024-01-08	No	No	Current
50090-7024-4	50090702404	50 TABLET in 1 BOTTLE (50090-7024-4)	50 tablet	2024-01-08	No	No	Current
50090-7024-5	50090702405	30 TABLET in 1 BOTTLE (50090-7024-5)	30 tablet	2024-01-08	No	No	Current
50090-7024-8	50090702408	40 TABLET in 1 BOTTLE (50090-7024-8)	40 tablet	2024-01-08	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	A-S Medication Solutions	2024-01-18	HUMAN PRESCRIPTION DRUG LABEL	1