Prednisone

Product NDC: 72162-1169
11-digit product format: 721621169
Labeler code: 72162
Product ID: 72162-1169_fb12ef7e-c438-446a-aace-fe4eb5cb7d8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA040584
Marketing category: ANDA
Marketing start: 2004-12-21
Substance: PREDNISONE
Active strength: 1 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

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	72162-1169	72162-1169-1	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 · 29 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 package	package	72162-1169-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72162-1169-1	`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	72162-1169-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72162-1169-0	`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	72162-1169-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72162-1169-0	`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	72162-1169-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72162-1169-0	`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	72162-1169-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72162-1169-0	`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	72162-1169-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72162-1169-0	`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	72162-1169-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72162-1169-0	`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	72162-1169-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72162-1169-0	`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	72162-1169-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72162-1169-0	`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	72162-1169-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72162-1169-0	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A040584-001	PREDNISONE	PREDNISONE	1MG	TABLET / ORAL	AB		2004-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040584-001	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 · 43 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	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A040584-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040584-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040584-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040584-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040584-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040584-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040584-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040584-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040584-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040584-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040584-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040584-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040584-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040584-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040584-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040584-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040584-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040584-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040584-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040584-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040584-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040584-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040584-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040584-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040584-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040584-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040584-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040584-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040584-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040584-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040584-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040584-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040584-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040584-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040584-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040584-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040584-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040584-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040584-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040584-001	AB	1	`f41ea6bd6efb…`

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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISONE	1 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
198144	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
0b2c2085-c4da-4441-ae5e-eefe26fd199e	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	Strength	SPL version
72162-1169-0	Prednisone	1000 in 1 BOTTLE	TABLET	1000		107
72162-1169-1	Prednisone	100 in 1 BOTTLE	TABLET	100		107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1169-0	EA - Each	72162-1169	fe1a3687-1986-48a5-8506-b0b91748899d	1	2023-05-05
72162-1169-1	EA - Each	72162-1169	cfcd5483-ae1e-414d-8d4e-97e2fcbf1474	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1169	PREDNISONE TABLET [BRYANT RANCH PREPACK]	106	Current NDC, 2 package rows	20250519_0b2c2085-c4da-4441-ae5e-eefe26fd199e.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Bryant Ranch Prepack	0062fcc7-aa08-4990-9d33-d798725907f1	2026-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040584 application number: ANDA040584
Prednisone	PREDNISONE	Par Health USA, LLC	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040584 application number: ANDA040584
Prednisone	PREDNISONE	Bryant Ranch Prepack	e4c1c8c5-0aa1-4531-aa7a-8567ac8dcba8	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040584 application number: ANDA040584
PREDNISONE	PREDNISONE	DIRECT RX	2a053775-6f6a-455e-b9a8-8b60e6062db3	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040584 application number: ANDA040584
Prednisone	PREDNISONE	Bryant Ranch Prepack	0b2c2085-c4da-4441-ae5e-eefe26fd199e	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040584 application number: ANDA040584 ndc (product): 72162-1169

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	0b2c2085-c4da-4441-ae5e-eefe26fd199e	107
198144	prednisone 1 MG Oral Tablet	SCD	0b2c2085-c4da-4441-ae5e-eefe26fd199e	107

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-1169-0	72162116900	1000 TABLET in 1 BOTTLE (72162-1169-0)	1000 tablet	2023-03-30	No	No	Current
72162-1169-1	72162116901	100 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg	Bryant Ranch Prepack	2025-04-25	HUMAN PRESCRIPTION DRUG LABEL	107