prednisone

Product NDC: 85766-086
Requested package NDC: 85766-086-05
11-digit product format: 857660086
Labeler code: 85766
Product ID: 85766-086_503196db-b234-c296-e063-6394a90ae483
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREDNISONE
Dosage form: TABLET
Route: ORAL
Labeler: Sportpharm LLC
Application: ANDA208412
Marketing category: ANDA
Marketing start: 2022-05-24
Substance: PREDNISONE
Active strength: 50 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISONE	50 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
198148	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
5dde7256-d3b8-400d-a0eb-c60078bfc5d9	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
85766-086-01	prednisone	100 in 1 BOTTLE	TABLET	100	2
85766-086-05	prednisone	5 in 1 BOTTLE	TABLET	5	2
85766-086-10	prednisone	10 in 1 BOTTLE	TABLET	10	2
85766-086-20	prednisone	20 in 1 BOTTLE	TABLET	20	2
85766-086-30	prednisone	30 in 1 BOTTLE	TABLET	30	2
85766-086-60	prednisone	60 in 1 BOTTLE	TABLET	60	2
85766-086-90	prednisone	90 in 1 BOTTLE	TABLET	90	2

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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	REMEDYREPACK INC.	23b12d22-97d6-426e-bf9c-dd6c2ff77370	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	1e74ac55-4a48-4bf5-bfed-36c0fa37dd9f	2026-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	ce7663a7-4c91-4790-aa43-96f259b3bb18	2026-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	REMEDYREPACK INC.	af5d0f73-2aef-4db1-ae25-6d465c9f0ca1	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	REMEDYREPACK INC.	5218e88b-468b-4d60-ab7e-78cca632b23a	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
Prednisone	PREDNISONE	Cardinal Health 107, LLC	cdc2b903-5d86-45c1-b97c-2da48445dbdd	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	St. Mary's Medical Park Pharmacy	e4437eec-eadf-7c8b-e053-2a95a90af846	2026-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Coupler LLC	53864d75-06ca-5c2a-e063-6394a90ad966	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Bryant Ranch Prepack	ecc48869-3812-4440-a398-749b28062059	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	American Health Packaging	fdcd49a6-6cb1-49f8-9f4c-feb475c129b3	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Cardinal Health 107, LLC	1d797f3e-a46c-42bc-91bb-c570ae8ca8c2	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	REMEDYREPACK INC.	ea4070e1-080d-4feb-9561-3910c6b712dd	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	REMEDYREPACK INC.	b3b70d6f-dc44-4a54-b39b-2762f37d5575	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	QPharma Inc	11870c93-fe64-e6c9-e063-6394a90a5334	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	QPharma Inc	f795ea1d-f41a-6100-e053-6394a90a63a4	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
Prednisone	PREDNISONE	Direct_Rx	f6051257-2144-4487-e053-2995a90a973b	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Bryant Ranch Prepack	fbfd4e2b-3c8f-43c8-bcbe-da1ac4be75c5	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Proficient Rx LP	4b37ada5-1f22-46d5-a794-fd1477c0eb9b	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Sportpharm LLC	5dde7256-d3b8-400d-a0eb-c60078bfc5d9	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412 ndc (package): 85766-086-05 ndc (product): 85766-086 ndc11 (package): 85766008605
prednisone	PREDNISONE	REMEDYREPACK INC.	e9a74862-6a3b-4247-837a-389761b5c352	2026-04-13	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
198148	predniSONE 50 MG Oral Tablet	PSN	5dde7256-d3b8-400d-a0eb-c60078bfc5d9	2
198148	prednisone 50 MG Oral Tablet	SCD	5dde7256-d3b8-400d-a0eb-c60078bfc5d9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85766-086-05	85766008605	5 TABLET in 1 BOTTLE (85766-086-05)	5 tablet	2025-10-10	No	No	Current