PREDNISONE

Product NDC: 71335-1524
Requested package NDC: 71335-1524-8
11-digit product format: 713351524
Labeler code: 71335
Product ID: 71335-1524_70e6bcae-2c9a-457f-8ba2-ff4a66859670
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA211495
Marketing category: ANDA
Marketing start: 2018-12-07
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 5 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-1524	71335-1524-8	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1524	71335-1524-8	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1524	71335-1524-8	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog.

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 · 42 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
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL		2018-12-07	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211495-002	PREDNISONE	5MG	TABLET / ORAL		2018-12-07	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211495-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211495-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211495-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211495-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211495-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211495-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211495-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211495-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211495-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211495-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211495-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211495-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211495-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211495-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211495-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211495-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211495-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211495-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211495-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211495-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211495-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211495-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211495-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211495-002	AB	1	`b00525d2431f…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211495-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211495-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211495-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211495-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211495-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A211495-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211495-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A211495-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211495-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211495-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211495-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A211495-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211495-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A211495-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211495-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211495-002	AB	1	`cb3db0bc1861…`

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
71335-1524-0	PREDNISONE	42 in 1 BOTTLE	TABLET	42	4
71335-1524-1	PREDNISONE	30 in 1 BOTTLE	TABLET	30	4
71335-1524-2	PREDNISONE	78 in 1 BOTTLE	TABLET	78	4
71335-1524-3	PREDNISONE	36 in 1 BOTTLE	TABLET	36	4
71335-1524-4	PREDNISONE	21 in 1 BOTTLE	TABLET	21	4
71335-1524-5	PREDNISONE	15 in 1 BOTTLE	TABLET	15	4
71335-1524-6	PREDNISONE	100 in 1 BOTTLE	TABLET	100	4
71335-1524-7	PREDNISONE	20 in 1 BOTTLE	TABLET	20	4
71335-1524-8	PREDNISONE	10 in 1 BOTTLE	TABLET	10	4
71335-1524-9	PREDNISONE	90 in 1 BOTTLE	TABLET	90	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1524	PREDNISONE TABLET [BRYANT RANCH PREPACK]	4	Legacy NDC, 10 package rows	20200929_87a01be9-26e9-4a94-941b-83ca7379d451.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Chartwell RX, LLC	36631112-3abb-4003-886b-9fe6d9cbe2cc	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211495 application number: ANDA211495

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	87a01be9-26e9-4a94-941b-83ca7379d451	4
312617	prednisone 5 MG Oral Tablet	SCD	87a01be9-26e9-4a94-941b-83ca7379d451	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1524-8	71335152408	10 TABLET in 1 BOTTLE (71335-1524-8)	10 tablet	2020-03-04	0000-00-00	No	No	Current