PREDNISONE

Product NDC: 0527-2931
11-digit product format: 005272931
Labeler code: 0527
Product ID: 0527-2931_53b9db92-5ba6-419d-949f-8d55538f110e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA211495
Marketing category: ANDA
Marketing start: 2018-12-07
Marketing end: 2023-01-31
Substance: PREDNISONE
Active strength: 3 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0527-2931		D	Discontinued by firm		2026-08-10
excluded package	package	0527-2931	0527-2931-37	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 · 24 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	0527-2931-37	`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	0527-2931-37	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-2931-37	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-2931-37	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-2931-37	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-2931-37	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-2931-37	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-2931-37	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-2931-37	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0527-2931-37	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0527-2931-37	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0527-2931-37	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-2931-37	EA - Each	0527-2931	5f5ae7e8-2a10-4c48-8b1b-7dda7ca7735a	1	2019-11-12

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
198146	predniSONE 2.5 MG Oral Tablet	PSN	01413391-910c-482c-8514-e469a18927ce	100
198146	prednisone 2.5 MG Oral Tablet	SCD	01413391-910c-482c-8514-e469a18927ce	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-2931-37	00527293137	100 TABLET in 1 BOTTLE (0527-2931-37)	100 tablet	2018-12-07	2023-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP	Preferred Pharmaceuticals Inc.	2022-09-28	HUMAN PRESCRIPTION DRUG LABEL	2
PredniSONE Tablets, USP	Bryant Ranch Prepack	2020-12-04	HUMAN PRESCRIPTION DRUG LABEL	100
PredniSONE Tablets, USP	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-07-16	HUMAN PRESCRIPTION DRUG LABEL	1
PredniSONE Tablets, USP	Lannett Company, Inc.	2019-04-30	HUMAN PRESCRIPTION DRUG LABEL	4