PREDNISONE

Product NDC: 71335-1926
11-digit product format: 713351926
Labeler code: 71335
Product ID: 71335-1926_5af7832a-71c0-403d-a77a-166b301a5da0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA211496
Marketing category: ANDA
Marketing start: 2018-12-28
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 1 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-1926		D	Discontinued by firm	2026-08-10
excluded package	package	71335-1926	71335-1926-1	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1926	71335-1926-2	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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1926-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1926-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1926-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1926-1	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211496-001	PREDNISONE	PREDNISONE	1MG	TABLET / ORAL			2018-12-28

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211496-001	PREDNISONE	1MG	TABLET / ORAL		2018-12-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211496-001	PREDNISONE	1MG	TABLET / ORAL	AB	2018-12-28	`cb3db0bc1861…`

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	A211496-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211496-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211496-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211496-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211496-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211496-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211496-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211496-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211496-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211496-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211496-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211496-001	AB	1	`b00525d2431f…`
2024-02-18 07:12 UTC	2024-02	A211496-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211496-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211496-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211496-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211496-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211496-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211496-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211496-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211496-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211496-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211496-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211496-001	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	Strength	SPL version
71335-1926-1	PREDNISONE	100 in 1 BOTTLE	TABLET	100		100
71335-1926-2	PREDNISONE	30 in 1 BOTTLE	TABLET	30		100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1926	PREDNISONE TABLET [BRYANT RANCH PREPACK]	100	Legacy NDC, 2 package rows	20210821_c0fbc2e8-0334-40af-b79b-313a46c0c6fe.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	f532c919-765d-407a-9e01-db2dc0c006f5	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211496 application number: ANDA211496

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
198144	predniSONE 1 MG Oral Tablet	PSN	c0fbc2e8-0334-40af-b79b-313a46c0c6fe	100
198144	prednisone 1 MG Oral Tablet	SCD	c0fbc2e8-0334-40af-b79b-313a46c0c6fe	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1926-1	71335192601	100 TABLET in 1 BOTTLE (71335-1926-1)	100 tablet	2021-08-11	0000-00-00	No	No	Current
71335-1926-2	71335192602	30 TABLET in 1 BOTTLE (71335-1926-2)	30 tablet	2021-08-11	0000-00-00	No	No	Current