Prednisone

Product NDC: 80425-0193
11-digit product format: 804250193
Labeler code: 80425
Product ID: 80425-0193_2a99a7c1-c4c6-2b01-e063-6294a90aa3b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA040362
Marketing category: ANDA
Marketing start: 2022-06-20
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040362-001	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29
A040362-002	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29
A040362-003	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29
A040362-004	PREDNISONE	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17
A040362-005	PREDNISONE	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A040362-001	AB
A040362-002	AB
A040362-003	AB
A040362-004	AB
A040362-005	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 5 · 167 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
2026-02-19 14:30 UTC	2026-02	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 167 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	A040362-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040362-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-005	AB	1	`5bbf6a4d5a75…`

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
e1e7d14b-80b2-f57e-e053-2995a90af112	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
80425-0193-1	Prednisone	21 in 1 BOTTLE	TABLET	21		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0193-1	EA - Each	80425-0193	f0b33e30-bd77-46ff-8633-71f2476a2ea1	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0193	PREDNISONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	4	Current NDC, Legacy NDC, 1 package rows	20250101_e1e7d14b-80b2-f57e-e053-2995a90af112.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	A-S Medication Solutions	74102cc5-7a1a-4a0f-a07f-a4b0f86bcabf	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	A-S Medication Solutions	dc94273f-af06-4bd5-9ce3-ce0a0f36587b	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	af863b9e-964b-3b1e-e053-2995a90ab93a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Advanced Rx Pharmacy of Tennessee, LLC	b3dbf833-b929-8c85-e053-2995a90a5896	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Advanced Rx Pharmacy of Tennessee, LLC	e1e7d14b-80b2-f57e-e053-2995a90af112	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362 ndc (product): 80425-0193
Prednisone	PREDNISONE	Advanced Rx Pharmacy of Tennessee, LLC	b3dbff9f-610f-7782-e053-2a95a90a71c1	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	62fdf3c2-cfa9-d573-e053-2a91aa0a833b	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	62ec965c-e682-9920-e053-2a91aa0adcdb	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	62ff1da3-79aa-676a-e053-2991aa0a4a9f	2024-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	A-S Medication Solutions	751b7f62-f92b-4b7c-a588-2c882d5d1ce3	2024-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	A-S Medication Solutions	cb1b0dc0-6916-4e6f-9775-26ea0f593f83	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	63106192-35d5-6989-e053-2991aa0aa714	2024-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	A-S Medication Solutions	5c8ffc9d-3804-40d3-ae2c-1fbac7bdc8d2	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	63102d75-9b2b-84a9-e053-2a91aa0a317d	2024-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Proficient Rx LP	5961b1d4-6a4c-452f-b3f1-c99f3a9a6445	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Asclemed USA, Inc.	dc663fd3-b149-48ae-a3f3-6abaa4808cc6	2020-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Proficient Rx LP	e4555299-af68-416f-8999-9bb703a45e77	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Proficient Rx LP	7c650dc8-43f6-4257-81ed-c93b00202d06	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362

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	e1e7d14b-80b2-f57e-e053-2995a90af112	4
198145	prednisone 10 MG Oral Tablet	SCD	e1e7d14b-80b2-f57e-e053-2995a90af112	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0193-1	80425019301	21 TABLET in 1 BOTTLE (80425-0193-1)	21 tablet	2024-06-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prednisone Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	4