Prednisone

Product NDC: 80425-0491
Requested package NDC: 80425-0491-1
11-digit product format: 804250491
Labeler code: 80425
Product ID: 80425-0491_309580ae-7ca3-e291-e063-6394a90adbc7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA085162
Marketing category: ANDA
Marketing start: 2025-03-17
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 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
A085162-001	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A085162-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`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	A085162-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085162-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085162-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085162-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085162-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085162-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085162-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085162-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085162-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085162-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085162-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085162-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085162-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085162-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085162-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085162-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085162-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085162-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085162-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085162-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085162-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085162-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085162-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085162-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085162-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085162-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085162-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085162-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085162-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085162-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085162-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085162-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085162-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085162-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085162-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085162-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085162-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085162-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085162-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085162-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Redpharm Drug	5407a00b-1bfb-e37d-e063-6294a90a6c41	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085162 application number: ANDA085162
Prednisone D/P	PREDNISONE D/P	Direct_Rx	41ade439-59f2-dfd1-e063-6294a90aca0f	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085162 application number: ANDA085162
Prednisone	PREDNISONE	Northwind Health Company, LLC	0f377d9f-b2f4-4dae-b503-5f963bea281f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085162 application number: ANDA085162
Prednisone	PREDNISONE	QPharma, Inc.	07fb8daa-2ceb-4564-b0d0-6cdf903da0b5	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085162 application number: ANDA085162
Prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	309580a7-c3bb-e53b-e063-6394a90a1563	2025-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085162 application number: ANDA085162 ndc (package): 80425-0491-1 ndc (product): 80425-0491 ndc11 (package): 80425049101
Prednisone	PREDNISONE	Actavis Pharma, Inc.	aa0b1582-6ef3-4697-9ea6-5391e6e57853	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085162 application number: ANDA085162
Prednisone	PREDNISONE	Proficient Rx LP	94f8ec56-667e-4eda-832d-f2936f12dc36	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085162 application number: ANDA085162

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
309580a7-c3bb-e53b-e063-6394a90a1563	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	Strength	SPL version
80425-0491-1	Prednisone	1 in 1 CARTON	TABLET	1		1
80425-0491-1	Prednisone	21 in 1 BLISTER PACK	TABLET	21		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0491-1	EA - Each	80425-0491	3f7163be-d6ca-4aa3-9be7-fca487004453	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0491	PREDNISONE TABLET [ADVANCED RX OF TENNESSEE, LLC]	1	Current NDC, 2 package rows	20250322_309580a7-c3bb-e53b-e063-6394a90a1563.zip

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	309580a7-c3bb-e53b-e063-6394a90a1563	1
198145	prednisone 10 MG Oral Tablet	SCD	309580a7-c3bb-e53b-e063-6394a90a1563	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0491-1	80425049101	1 BLISTER PACK in 1 CARTON (80425-0491-1) / 21 TABLET in 1 BLISTER PACK	1 blister pack	2025-03-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
predniSONE Tablets, USP Rx only	Advanced Rx of Tennessee, LLC	2025-03-17	HUMAN PRESCRIPTION DRUG LABEL	1