PREDNISONE

Product NDC: 71335-2389
Requested package NDC: 71335-2389-7
11-digit product format: 713352389
Labeler code: 71335
Product ID: 71335-2389_1fb23895-41de-4fe6-92fc-1b6d6721b73a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREDNISONE
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA215672
Marketing category: ANDA
Marketing start: 2022-03-28
Substance: PREDNISONE
Active strength: 50 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
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: 2026-12-31

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
7601e38d-b7d2-4292-b16e-abff32bb46b3	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
71335-2389-1	PREDNISONE	90 in 1 BOTTLE	TABLET	90	1
71335-2389-2	PREDNISONE	5 in 1 BOTTLE	TABLET	5	1
71335-2389-3	PREDNISONE	30 in 1 BOTTLE	TABLET	30	1
71335-2389-4	PREDNISONE	60 in 1 BOTTLE	TABLET	60	1
71335-2389-5	PREDNISONE	120 in 1 BOTTLE	TABLET	120	1
71335-2389-6	PREDNISONE	7 in 1 BOTTLE	TABLET	7	1
71335-2389-7	PREDNISONE	20 in 1 BOTTLE	TABLET	20	1
71335-2389-8	PREDNISONE	10 in 1 BOTTLE	TABLET	10	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2389	PREDNISONE TABLET [BRYANT RANCH PREPACK]	1	Current NDC, 8 package rows	20240531_7601e38d-b7d2-4292-b16e-abff32bb46b3.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 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREDNISONE	PREDNISONE	REMEDYREPACK INC.	0993b354-d936-472b-bafc-114f0f81bfb0	2026-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	Proficient Rx LP	eabbefb2-21a9-4745-8021-1aac1ece7f9d	2026-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals,Inc.	288ecb6d-3b0b-db95-e063-6394a90a78ff	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	ST. MARY'S MEDICAL PARK PHARMACY	42e0decc-4d11-e7e6-e063-6394a90a9fcc	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	Coupler LLC	50734a48-807d-cc00-e063-6294a90a4dae	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	A-S Medication Solutions	53c66f70-58fd-4d4c-b054-e5cefdc0c637	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	A-S Medication Solutions	e753e2bc-acca-46eb-888c-ae72fcac6ca4	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	A-S Medication Solutions	a8f6298a-1084-4226-bfd9-a543a26ad2e7	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals, Inc.	2760a808-b076-5887-e063-6294a90a79ae	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	QPharma, Inc.	4aa286e3-e272-8095-e063-6394a90ae871	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	ASCLEMED USA INC.	bf6ebe58-e7bb-49d3-842e-3372f8ba6172	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals, Inc.	292e2529-711c-7b74-e063-6394a90a660d	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	REMEDYREPACK INC.	ab9bffed-b1a2-4e82-ac45-bee40b41060f	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	A-S Medication Solutions	35de14e3-d748-46bd-a307-6a1a27c626a2	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	Redpharm Drug	44f5e966-5a12-e2ff-e063-6294a90a919e	2025-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	Coupler LLC	41e6f1c3-d225-0ff0-e063-6394a90ace88	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	c21be016-6b25-4e09-b253-23b58884ccb6	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	Preferred Pharmaceuticals Inc.	28130e6d-7cda-459a-9f80-cacaa82d71d3	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals,Inc.	27d8dcad-a024-ed85-e063-6394a90a420d	2025-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215672 application number: ANDA215672
PREDNISONE	PREDNISONE	Preferred Pharmaceuticals Inc.	60bb6698-d1fc-4720-9954-266a3d650f0d	2025-04-29	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
198148	predniSONE 50 MG Oral Tablet	PSN	7601e38d-b7d2-4292-b16e-abff32bb46b3	1
198148	prednisone 50 MG Oral Tablet	SCD	7601e38d-b7d2-4292-b16e-abff32bb46b3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2389-7	71335238907	20 TABLET in 1 BOTTLE (71335-2389-7)	20 tablet	2024-05-29	No	No	Current