PREDNISONE

Product NDC: 71205-537
Requested package NDC: 71205-537-30
11-digit product format: 712050537
Labeler code: 71205
Product ID: 71205-537_3ce81e99-e007-4186-8814-4bd44e078141
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71205-537	71205-537-30	D	Discontinued by firm		2026-10-05

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	71205-537	71205-537-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-537	71205-537-30	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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-537-21	EA - Each	71205-537	84282346-cd09-49bd-9db5-c0a6a17534a3	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-537	PREDNISONE TABLET [PROFICIENT RX LP]	1	Legacy NDC	20210529_3ce81e99-e007-4186-8814-4bd44e078141.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-537-30	71205053730	30 TABLET in 1 BOTTLE (71205-537-30)	30 tablet	2021-05-21	0000-00-00	No	No	Current