prednisone

Product NDC: 80425-0484
11-digit product format: 804250484
Labeler code: 80425
Product ID: 80425-0484_31fa0646-b734-4e96-e063-6394a90a6b66
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREDNISONE
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA208412
Marketing category: ANDA
Marketing start: 2025-01-31
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 43.

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
A208412-001	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11
A208412-002	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11
A208412-003	PREDNISONE	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11
A208412-004	PREDNISONE	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20
A208412-005	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208412-001	AB
A208412-002	AB
A208412-003	AB
A208412-004	AB
A208412-005	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 4 · 136 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	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 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	A208412-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208412-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208412-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208412-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198145	Internal RxNorm lookup
312615	Internal RxNorm lookup
312617	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
2d0562ad-6175-833c-e063-6394a90ad029	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
80425-0484-1	prednisone	21 in 1 BOTTLE, PLASTIC	TABLET	21		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0484-1	EA - Each	80425-0484	45631ccf-0e70-47eb-ac42-a4023e1fc60f	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0484	PREDNISONE TABLET [ADVANCED RX OF TENNESSEE, LLC]	3	Current NDC, 1 package rows	20250410_2d0562ad-6175-833c-e063-6394a90ad029.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 3 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	A-S Medication Solutions	f4cc64f8-781f-437a-a4a7-2d163026d1c2	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Bryant Ranch Prepack	4433a882-ff79-4a9d-8db8-1977c5cd04cf	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Bryant Ranch Prepack	a2ba1a31-9e2d-4c1e-9bbd-b813831ce08f	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	A-S Medication Solutions	c7c3bb80-73b6-4128-aa5f-0d465a1d84e8	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals,Inc.	db4a13ff-546d-15b7-e053-2a95a90a6adf	2024-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Medsource Pharmaceuticals	131780a0-31f3-6588-e063-6294a90a2f8e	2024-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Proficient Rx LP	22d9fd96-cad5-4762-9a56-0ff63357ed9e	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412

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	2d0562ad-6175-833c-e063-6394a90ad029	3
312615	predniSONE 20 MG Oral Tablet	PSN	2d0562ad-6175-833c-e063-6394a90ad029	3
312617	predniSONE 5 MG Oral Tablet	PSN	2d0562ad-6175-833c-e063-6394a90ad029	3
198145	prednisone 10 MG Oral Tablet	SCD	2d0562ad-6175-833c-e063-6394a90ad029	3
312615	prednisone 20 MG Oral Tablet	SCD	2d0562ad-6175-833c-e063-6394a90ad029	3
312617	prednisone 5 MG Oral Tablet	SCD	2d0562ad-6175-833c-e063-6394a90ad029	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0484-1	80425048401	21 TABLET in 1 BOTTLE, PLASTIC (80425-0484-1)	21 tablet	2025-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prednisone Tablets USP Rx only	Advanced Rx of Tennessee, LLC	2025-04-04	HUMAN PRESCRIPTION DRUG LABEL	3