PREDNISONE

Product NDC: 87063-044
11-digit product format: 870630044
Labeler code: 87063
Product ID: 87063-044_4a1001c0-0013-e6a5-e063-6294a90af48e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREDNISONE
Dosage form: TABLET
Route: ORAL
Labeler: ASCLEMED USA INC.
Application: ANDA215672
Marketing category: ANDA
Marketing start: 2022-03-28
Substance: PREDNISONE
Active strength: 10 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
A215672-001	PREDNISONE	PREDNISONE	2.5MG	TABLET / ORAL	AB	2022-03-28
A215672-002	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	2022-03-28
A215672-003	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB	2022-03-28
A215672-004	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	2022-03-28
A215672-005	PREDNISONE	PREDNISONE	50MG	TABLET / ORAL	AB	2022-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215672-001	AB
A215672-002	AB
A215672-003	AB
A215672-004	AB
A215672-005	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 · 160 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	A215672-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2022-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215672-002	PREDNISONE	5MG	TABLET / ORAL	AB	2022-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215672-003	PREDNISONE	10MG	TABLET / ORAL	AB	2022-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215672-004	PREDNISONE	20MG	TABLET / ORAL	AB	2022-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215672-005	PREDNISONE	50MG	TABLET / ORAL	AB	2022-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215672-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2022-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215672-002	PREDNISONE	5MG	TABLET / ORAL	AB	2022-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215672-003	PREDNISONE	10MG	TABLET / ORAL	AB	2022-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215672-004	PREDNISONE	20MG	TABLET / ORAL	AB	2022-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215672-005	PREDNISONE	50MG	TABLET / ORAL	AB	2022-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215672-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2022-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215672-002	PREDNISONE	5MG	TABLET / ORAL	AB	2022-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215672-003	PREDNISONE	10MG	TABLET / ORAL	AB	2022-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215672-004	PREDNISONE	20MG	TABLET / ORAL	AB	2022-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215672-005	PREDNISONE	50MG	TABLET / ORAL	AB	2022-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215672-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2022-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215672-002	PREDNISONE	5MG	TABLET / ORAL	AB	2022-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215672-003	PREDNISONE	10MG	TABLET / ORAL	AB	2022-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215672-004	PREDNISONE	20MG	TABLET / ORAL	AB	2022-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215672-005	PREDNISONE	50MG	TABLET / ORAL	AB	2022-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215672-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2022-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215672-002	PREDNISONE	5MG	TABLET / ORAL	AB	2022-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215672-003	PREDNISONE	10MG	TABLET / ORAL	AB	2022-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215672-004	PREDNISONE	20MG	TABLET / ORAL	AB	2022-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215672-005	PREDNISONE	50MG	TABLET / ORAL	AB	2022-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215672-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2022-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215672-002	PREDNISONE	5MG	TABLET / ORAL	AB	2022-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215672-003	PREDNISONE	10MG	TABLET / ORAL	AB	2022-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215672-004	PREDNISONE	20MG	TABLET / ORAL	AB	2022-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215672-005	PREDNISONE	50MG	TABLET / ORAL	AB	2022-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215672-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2022-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215672-002	PREDNISONE	5MG	TABLET / ORAL	AB	2022-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215672-003	PREDNISONE	10MG	TABLET / ORAL	AB	2022-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215672-004	PREDNISONE	20MG	TABLET / ORAL	AB	2022-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215672-005	PREDNISONE	50MG	TABLET / ORAL	AB	2022-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215672-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2022-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215672-002	PREDNISONE	5MG	TABLET / ORAL	AB	2022-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215672-003	PREDNISONE	10MG	TABLET / ORAL	AB	2022-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215672-004	PREDNISONE	20MG	TABLET / ORAL	AB	2022-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215672-005	PREDNISONE	50MG	TABLET / ORAL	AB	2022-03-28	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 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	A215672-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215672-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215672-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215672-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215672-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215672-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215672-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215672-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215672-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215672-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215672-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215672-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215672-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215672-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215672-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215672-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215672-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215672-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215672-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215672-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215672-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215672-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215672-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215672-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215672-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215672-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215672-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215672-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215672-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215672-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215672-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215672-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215672-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215672-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215672-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215672-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215672-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215672-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215672-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215672-005	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	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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198145	Internal RxNorm lookup
198146	Internal RxNorm lookup
198148	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
bf6ebe58-e7bb-49d3-842e-3372f8ba6172	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
87063-044-01	PREDNISONE	100 in 1 BOTTLE	TABLET	100	2
87063-044-18	PREDNISONE	18 in 1 BOTTLE	TABLET	18	2
87063-044-20	PREDNISONE	20 in 1 BOTTLE	TABLET	20	2
87063-044-21	PREDNISONE	21 in 1 BOTTLE	TABLET	21	2
87063-044-30	PREDNISONE	30 in 1 BOTTLE	TABLET	30	2
87063-044-60	PREDNISONE	60 in 1 BOTTLE	TABLET	60	2
87063-044-78	PREDNISONE	10 in 1 CARTON	TABLET	10	2
87063-044-78	PREDNISONE	10 in 1 BLISTER PACK	TABLET	10	2
87063-044-90	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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREDNISONE	PREDNISONE	Advanced Rx of Tennessee, LLC	2e62cf2e-dcbf-c15e-e063-6294a90a8168	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	Preferred Pharmaceuticals Inc.	94d82acb-ff31-492f-bd51-b23e15d881d6	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals, Inc.	28f2733e-963e-f0e0-e063-6394a90a0a9d	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	A-S Medication Solutions	3bfdc4d7-ba8e-422a-96e3-3c3ba587eab1	2024-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals,Inc.	1c59f8a1-e287-865f-e063-6394a90aa330	2024-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	Bryant Ranch Prepack	7601e38d-b7d2-4292-b16e-abff32bb46b3	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	Bryant Ranch Prepack	29c96865-48be-4898-81b7-a6fc9623d3b9	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	Aurobindo Pharma Limited	b1ac4c92-e1fd-4015-b172-0932790ae019	2024-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672

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	bf6ebe58-e7bb-49d3-842e-3372f8ba6172	2
198146	predniSONE 2.5 MG Oral Tablet	PSN	bf6ebe58-e7bb-49d3-842e-3372f8ba6172	2
312615	predniSONE 20 MG Oral Tablet	PSN	bf6ebe58-e7bb-49d3-842e-3372f8ba6172	2
312617	predniSONE 5 MG Oral Tablet	PSN	bf6ebe58-e7bb-49d3-842e-3372f8ba6172	2
198148	predniSONE 50 MG Oral Tablet	PSN	bf6ebe58-e7bb-49d3-842e-3372f8ba6172	2
198145	prednisone 10 MG Oral Tablet	SCD	bf6ebe58-e7bb-49d3-842e-3372f8ba6172	2
198146	prednisone 2.5 MG Oral Tablet	SCD	bf6ebe58-e7bb-49d3-842e-3372f8ba6172	2
312615	prednisone 20 MG Oral Tablet	SCD	bf6ebe58-e7bb-49d3-842e-3372f8ba6172	2
312617	prednisone 5 MG Oral Tablet	SCD	bf6ebe58-e7bb-49d3-842e-3372f8ba6172	2
198148	prednisone 50 MG Oral Tablet	SCD	bf6ebe58-e7bb-49d3-842e-3372f8ba6172	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87063-044-01	87063004401	100 TABLET in 1 BOTTLE (87063-044-01)	100 tablet	2025-12-03	No	No	Current
87063-044-18	87063004418	18 TABLET in 1 BOTTLE (87063-044-18)	18 tablet	2025-12-03	No	No	Current
87063-044-20	87063004420	20 TABLET in 1 BOTTLE (87063-044-20)	20 tablet	2025-12-03	No	No	Current
87063-044-21	87063004421	21 TABLET in 1 BOTTLE (87063-044-21)	21 tablet	2025-12-03	No	No	Current
87063-044-30	87063004430	30 TABLET in 1 BOTTLE (87063-044-30)	30 tablet	2025-12-03	No	No	Current
87063-044-60	87063004460	60 TABLET in 1 BOTTLE (87063-044-60)	60 tablet	2025-12-03	No	No	Current
87063-044-78	87063004478	10 BLISTER PACK in 1 CARTON (87063-044-78) / 10 TABLET in 1 BLISTER PACK	10 blister pack	2025-12-03	No	No	Current
87063-044-90	87063004490	90 TABLET in 1 BOTTLE (87063-044-90)	90 tablet	2025-12-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prednisone Tablets, USP Rx only	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-02-05	HUMAN PRESCRIPTION DRUG LABEL	2