PredniSONE Tablets, USP, 5 mg

Product NDC: 71335-2753
Requested package NDC: 71335-2753-2
11-digit product format: 713352753
Labeler code: 71335
Product ID: 71335-2753_d41fab26-b03f-4bee-a72a-06829cf538d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PredniSONE
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA212629
Marketing category: ANDA
Marketing start: 2025-05-22
Substance: PREDNISONE
Active strength: 5 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212629-001	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	2023-12-05
A212629-002	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB	2023-12-05
A212629-003	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	2023-12-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212629-001	AB
A212629-002	AB
A212629-003	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 2 · 60 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	A212629-001	PREDNISONE	5MG	TABLET / ORAL	AB	2023-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212629-002	PREDNISONE	10MG	TABLET / ORAL	AB	2023-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212629-003	PREDNISONE	20MG	TABLET / ORAL	AB	2023-12-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212629-001	PREDNISONE	5MG	TABLET / ORAL	AB	2023-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212629-002	PREDNISONE	10MG	TABLET / ORAL	AB	2023-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212629-003	PREDNISONE	20MG	TABLET / ORAL	AB	2023-12-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212629-001	PREDNISONE	5MG	TABLET / ORAL	AB	2023-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212629-002	PREDNISONE	10MG	TABLET / ORAL	AB	2023-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212629-003	PREDNISONE	20MG	TABLET / ORAL	AB	2023-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212629-001	PREDNISONE	5MG	TABLET / ORAL	AB	2023-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212629-002	PREDNISONE	10MG	TABLET / ORAL	AB	2023-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212629-003	PREDNISONE	20MG	TABLET / ORAL	AB	2023-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212629-001	PREDNISONE	5MG	TABLET / ORAL	AB	2023-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212629-002	PREDNISONE	10MG	TABLET / ORAL	AB	2023-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212629-003	PREDNISONE	20MG	TABLET / ORAL	AB	2023-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212629-001	PREDNISONE	5MG	TABLET / ORAL	AB	2023-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212629-002	PREDNISONE	10MG	TABLET / ORAL	AB	2023-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212629-003	PREDNISONE	20MG	TABLET / ORAL	AB	2023-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212629-001	PREDNISONE	5MG	TABLET / ORAL	AB	2023-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212629-002	PREDNISONE	10MG	TABLET / ORAL	AB	2023-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212629-003	PREDNISONE	20MG	TABLET / ORAL	AB	2023-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212629-001	PREDNISONE	5MG	TABLET / ORAL	AB	2023-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212629-002	PREDNISONE	10MG	TABLET / ORAL	AB	2023-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212629-003	PREDNISONE	20MG	TABLET / ORAL	AB	2023-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212629-001	PREDNISONE	5MG	TABLET / ORAL		2023-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212629-002	PREDNISONE	10MG	TABLET / ORAL		2023-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212629-003	PREDNISONE	20MG	TABLET / ORAL		2023-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212629-001	PREDNISONE	5MG	TABLET / ORAL		2023-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212629-002	PREDNISONE	10MG	TABLET / ORAL		2023-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212629-003	PREDNISONE	20MG	TABLET / ORAL		2023-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212629-001	PREDNISONE	5MG	TABLET / ORAL		2023-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212629-002	PREDNISONE	10MG	TABLET / ORAL		2023-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212629-003	PREDNISONE	20MG	TABLET / ORAL		2023-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212629-001	PREDNISONE	5MG	TABLET / ORAL		2023-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212629-002	PREDNISONE	10MG	TABLET / ORAL		2023-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212629-003	PREDNISONE	20MG	TABLET / ORAL		2023-12-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212629-001	PREDNISONE	5MG	TABLET / ORAL		2023-12-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212629-002	PREDNISONE	10MG	TABLET / ORAL		2023-12-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212629-003	PREDNISONE	20MG	TABLET / ORAL		2023-12-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212629-001	PREDNISONE	5MG	TABLET / ORAL	AB	2023-12-05	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 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	A212629-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212629-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212629-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212629-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212629-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212629-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212629-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212629-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212629-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212629-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212629-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212629-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212629-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212629-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212629-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212629-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212629-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212629-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212629-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212629-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212629-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212629-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212629-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212629-003	AB	1	`03ed91905a0d…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212629-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212629-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212629-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212629-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212629-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212629-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212629-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212629-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212629-003	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212629-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212629-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212629-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212629-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212629-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212629-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212629-001	AB	1	`ea1830bbd6c7…`

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 Tablets, USP, 5 mg
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISONE	5 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
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
419058f7-7f30-41a1-964b-8eaa69290dea	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
71335-2753-0	PredniSONE Tablets, USP, 5 mg	42 in 1 BOTTLE	TABLET	42	1
71335-2753-1	PredniSONE Tablets, USP, 5 mg	30 in 1 BOTTLE	TABLET	30	1
71335-2753-2	PredniSONE Tablets, USP, 5 mg	78 in 1 BOTTLE	TABLET	78	1
71335-2753-3	PredniSONE Tablets, USP, 5 mg	36 in 1 BOTTLE	TABLET	36	1
71335-2753-4	PredniSONE Tablets, USP, 5 mg	21 in 1 BOTTLE	TABLET	21	1
71335-2753-5	PredniSONE Tablets, USP, 5 mg	15 in 1 BOTTLE	TABLET	15	1
71335-2753-6	PredniSONE Tablets, USP, 5 mg	100 in 1 BOTTLE	TABLET	100	1
71335-2753-7	PredniSONE Tablets, USP, 5 mg	20 in 1 BOTTLE	TABLET	20	1
71335-2753-8	PredniSONE Tablets, USP, 5 mg	10 in 1 BOTTLE	TABLET	10	1
71335-2753-9	PredniSONE Tablets, USP, 5 mg	90 in 1 BOTTLE	TABLET	90	1

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 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PredniSONE Tablets, USP, 20 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	6b360c1f-c862-47ee-a40e-3903c2d6162f	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 20 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	15230866-f547-47bf-ac7d-19afd6a41e2e	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 10 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	bb32e309-e3c7-4009-bcd4-d97545b7e975	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 5 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	251e9fe7-b1f5-4b5b-b5fa-8c8be43e284e	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 20 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	3befbdc5-7d20-41b6-ad80-98e1c6b8caf5	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 5 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	d6df3295-3118-49af-be05-b1fab0d4adaa	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 10 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	14d50f54-410b-45b2-a639-31498ceaf854	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 20 mg	PREDNISONE	Bryant Ranch Prepack	852ea185-1bda-4c89-a192-ee0f93cba428	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 5 mg	PREDNISONE	Bryant Ranch Prepack	475c6480-2a6a-4698-aff3-7affb154f2a7	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 20 mg	PREDNISONE	Bryant Ranch Prepack	0e55a02d-2de4-42c4-adc2-49536b899225	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 10 mg	PREDNISONE	Bryant Ranch Prepack	61dab6c2-4019-4d7c-bc8b-3a0a463beefc	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 20 mg	PREDNISONE	Bryant Ranch Prepack	53bd04e8-6cbd-45f6-ac59-53fd3005a221	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 10 mg	PREDNISONE	Bryant Ranch Prepack	8520622e-c0e3-4226-be84-e332ab98e6a7	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 5 mg	PREDNISONE	Bryant Ranch Prepack	5e5c81bf-7cbb-4f02-b107-16efe3d353ee	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 5 mg	PREDNISONE	Bryant Ranch Prepack	83e825cc-fb19-48b9-9f15-6aba6b1cef57	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 10 mg	PREDNISONE	Bryant Ranch Prepack	95b7de4c-9c69-45f6-9221-a2c87c441b04	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 5 mg	PREDNISONE	Bryant Ranch Prepack	419058f7-7f30-41a1-964b-8eaa69290dea	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629 ndc (package): 71335-2753-2 ndc (product): 71335-2753 ndc11 (package): 71335275302
PredniSONE Tablets, USP, 20 mg	PREDNISONE	Bryant Ranch Prepack	b42adc18-21cc-4fe0-bf7d-fb76f4cda215	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 20 mg	PREDNISONE	Bryant Ranch Prepack	bfcc98b8-184e-4db4-8079-de88958c774b	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629
PredniSONE Tablets, USP, 10 mg	PREDNISONE	Bryant Ranch Prepack	aba52f0c-0706-46ac-957d-e53963d35499	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212629 application number: ANDA212629

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
312617	predniSONE 5 MG Oral Tablet	PSN	419058f7-7f30-41a1-964b-8eaa69290dea	1
312617	prednisone 5 MG Oral Tablet	SCD	419058f7-7f30-41a1-964b-8eaa69290dea	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2753-2	71335275302	78 TABLET in 1 BOTTLE (71335-2753-2)	78 tablet	2025-10-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets USP, 5 mg, 10 mg, and 20 mg	Bryant Ranch Prepack	2025-10-03	HUMAN PRESCRIPTION DRUG LABEL	1