Prednisone

Product NDC: 80425-0486
Requested package NDC: 80425-0486-2
11-digit product format: 804250486
Labeler code: 80425
Product ID: 80425-0486_31fa1bbe-5072-482a-e063-6394a90aff74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA211575
Marketing category: ANDA
Marketing start: 2025-03-17
Substance: PREDNISONE
Active strength: 20 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
A211575-001	PREDNISONE	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15
A211575-002	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15
A211575-003	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15
A211575-004	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15
A211575-005	PREDNISONE	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211575-001	AB
A211575-002	AB
A211575-003	AB
A211575-004	AB
A211575-005	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 · 200 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	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 200 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	A211575-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211575-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211575-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211575-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211575-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-005	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	20 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
312615	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
30956dd5-fe19-d5a9-e063-6394a90a2549	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
80425-0486-1	Prednisone	21 in 1 BOTTLE	TABLET	21	2
80425-0486-2	Prednisone	14 in 1 BOTTLE	TABLET	14	2
80425-0486-3	Prednisone	10 in 1 BOTTLE	TABLET	10	2
80425-0486-4	Prednisone	15 in 1 BOTTLE	TABLET	15	2
80425-0486-5	Prednisone	20 in 1 BOTTLE	TABLET	20	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0486-1	EA - Each	80425-0486	14b47980-5e35-4c21-81e3-9783b105b214	1	2025-05-14
80425-0486-2	EA - Each	80425-0486	ec265645-937d-4699-9c0a-e0f5196c43c8	1	2025-05-14
80425-0486-3	EA - Each	80425-0486	56012a15-551c-4149-896d-54de13c60227	1	2025-05-14
80425-0486-4	EA - Each	80425-0486	c41b5398-3087-42d4-bbc9-1eb784ab9acc	1	2025-05-14
80425-0486-5	EA - Each	80425-0486	52b341a3-b8aa-4964-bd16-6b9c29c8b888	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0486	PREDNISONE TABLET [ADVANCED RX OF TENNESSEE, LLC]	2	Current NDC, 5 package rows	20250410_30956dd5-fe19-d5a9-e063-6394a90a2549.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Bryant Ranch Prepack	c60a07f9-ed9f-4434-a69d-2e2fea4843fd	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	Bryant Ranch Prepack	7ea7f6a9-78ef-42fe-baac-f817da3976fb	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	19fdbf9f-3a64-b9fa-e063-6394a90af086	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	1a9f00ac-ec92-4d2c-e063-6394a90ac4f6	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	25b5958b-c151-9200-e063-6394a90af52c	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	1349a022-639b-4494-99a2-1594c7c0f0e9	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	ANI Pharmaceuticals, Inc.	f05eb734-07e7-491c-b2e9-aae340e03750	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	St. Mary's Medical Park Pharmacy	1b3ea4cc-5bc6-ae47-e063-6294a90af13d	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	Aphena Pharma Solutions - Tennessee, LLC	18818282-68aa-82e9-e063-6394a90aef54	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone D/P	PREDNISONE D/P	Direct_Rx	4f0a3946-025c-798a-e063-6294a90a831b	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	Northwind Health Company, LLC	fbd3f0c3-06b3-c9b4-e053-6294a90a6fdd	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	Marlex Pharmaceuticals, Inc.	f499197b-b9b7-1707-e053-2a95a90a0932	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	Proficient Rx LP	08973b30-8576-4d31-aeef-934b72124e1f	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	30956dd5-fe19-d5a9-e063-6394a90a2549	2025-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575 ndc (package): 80425-0486-2 ndc (product): 80425-0486 ndc11 (package): 80425048602
Prednisone	PREDNISONE	NuCare Pharmaceuticals, Inc.	31cfc21f-726b-ae80-e063-6294a90a9af4	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	1b42449a-2be8-e4fb-e063-6394a90aff98	2024-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	1c33879e-8b2b-5843-e063-6294a90adea4	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	A-S Medication Solutions	8f7a38c7-7bf9-4951-b529-947cc9a57d6a	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	Proficient Rx LP	71d70ec6-859a-4951-af98-248a864e1135	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	Proficient Rx LP	67681e4e-3002-4428-af5e-6ff1a950b037	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575

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
312615	predniSONE 20 MG Oral Tablet	PSN	30956dd5-fe19-d5a9-e063-6394a90a2549	2
312615	prednisone 20 MG Oral Tablet	SCD	30956dd5-fe19-d5a9-e063-6394a90a2549	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0486-2	80425048602	14 TABLET in 1 BOTTLE (80425-0486-2)	14 tablet	2025-03-17	No	No	Current