PREDNISONE

Product NDC: 72189-246
11-digit product format: 721890246
Labeler code: 72189
Product ID: 72189-246_cc330c63-1bb0-210d-e053-2995a90a2545
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREDNISONE
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA210525
Marketing category: ANDA
Marketing start: 2021-07-08
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 50 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72189-246		I	Inactivated by FDA		2026-08-10
excluded package	package	72189-246	72189-246-07	I	Inactivated by FDA		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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72189-246-07	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72189-246-07	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72189-246-07	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72189-246-07	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72189-246-07	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72189-246-07	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72189-246-07	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-246-07	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-246-07	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A210525-001	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	2018-12-04
A210525-002	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	2018-12-04
A210525-003	PREDNISONE	PREDNISONE	50MG	TABLET / ORAL	2018-12-04
A210525-004	PREDNISONE	PREDNISONE	2.5MG	TABLET / ORAL	2018-12-07
A210525-005	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	2018-12-07

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 5 · 163 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210525-001	PREDNISONE	10MG	TABLET / ORAL	2018-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210525-002	PREDNISONE	20MG	TABLET / ORAL	2018-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210525-003	PREDNISONE	50MG	TABLET / ORAL	2018-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210525-004	PREDNISONE	2.5MG	TABLET / ORAL	2018-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210525-005	PREDNISONE	5MG	TABLET / ORAL	2018-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210525-001	PREDNISONE	10MG	TABLET / ORAL	2018-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210525-002	PREDNISONE	20MG	TABLET / ORAL	2018-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210525-003	PREDNISONE	50MG	TABLET / ORAL	2018-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210525-004	PREDNISONE	2.5MG	TABLET / ORAL	2018-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210525-005	PREDNISONE	5MG	TABLET / ORAL	2018-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210525-001	PREDNISONE	10MG	TABLET / ORAL	2018-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210525-002	PREDNISONE	20MG	TABLET / ORAL	2018-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210525-003	PREDNISONE	50MG	TABLET / ORAL	2018-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210525-004	PREDNISONE	2.5MG	TABLET / ORAL	2018-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210525-005	PREDNISONE	5MG	TABLET / ORAL	2018-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210525-001	PREDNISONE	10MG	TABLET / ORAL	2018-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210525-002	PREDNISONE	20MG	TABLET / ORAL	2018-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210525-003	PREDNISONE	50MG	TABLET / ORAL	2018-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210525-004	PREDNISONE	2.5MG	TABLET / ORAL	2018-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210525-005	PREDNISONE	5MG	TABLET / ORAL	2018-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210525-001	PREDNISONE	10MG	TABLET / ORAL	2018-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210525-002	PREDNISONE	20MG	TABLET / ORAL	2018-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210525-003	PREDNISONE	50MG	TABLET / ORAL	2018-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210525-004	PREDNISONE	2.5MG	TABLET / ORAL	2018-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210525-005	PREDNISONE	5MG	TABLET / ORAL	2018-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210525-001	PREDNISONE	10MG	TABLET / ORAL	2018-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210525-002	PREDNISONE	20MG	TABLET / ORAL	2018-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210525-003	PREDNISONE	50MG	TABLET / ORAL	2018-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210525-004	PREDNISONE	2.5MG	TABLET / ORAL	2018-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210525-005	PREDNISONE	5MG	TABLET / ORAL	2018-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210525-001	PREDNISONE	10MG	TABLET / ORAL	2018-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210525-002	PREDNISONE	20MG	TABLET / ORAL	2018-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210525-003	PREDNISONE	50MG	TABLET / ORAL	2018-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210525-004	PREDNISONE	2.5MG	TABLET / ORAL	2018-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210525-005	PREDNISONE	5MG	TABLET / ORAL	2018-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210525-001	PREDNISONE	10MG	TABLET / ORAL	2018-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210525-002	PREDNISONE	20MG	TABLET / ORAL	2018-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210525-003	PREDNISONE	50MG	TABLET / ORAL	2018-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210525-004	PREDNISONE	2.5MG	TABLET / ORAL	2018-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210525-005	PREDNISONE	5MG	TABLET / ORAL	2018-12-07	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

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	A210525-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210525-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210525-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210525-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210525-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210525-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210525-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210525-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210525-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210525-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210525-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210525-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210525-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210525-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210525-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210525-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210525-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210525-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210525-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210525-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210525-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210525-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210525-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210525-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210525-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210525-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210525-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210525-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210525-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210525-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210525-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210525-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210525-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210525-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A210525-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A210525-003	AB	1	`b00525d2431f…`
2024-02-18 07:12 UTC	2024-02	A210525-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210525-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210525-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210525-004	AB	1	`1c564ffb4f44…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72189-246-07	2025-01-30	C162847	48780-1	2cef2736-9b31-d83d-e063-dadaa90ab31f	PREDNISONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-246-07	PREDNISONE	7 in 1 BOTTLE	TABLET	7		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-246-07	EA - Each	72189-246	d59abf16-5e37-426d-b2ec-e3e50261ee4e	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-246	PREDNISONE TABLET [DIRECT RX]	2	Legacy NDC, 1 package rows	20210918_c69e83a3-5217-ab76-e053-2995a90ae7c0.zip

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	c69e83a3-5217-ab76-e053-2995a90ae7c0	2
198148	predniSONE 50 MG Oral Tablet	PSN	c69e83a3-5217-ab76-e053-2995a90ae7c0	2
312617	prednisone 5 MG Oral Tablet	SCD	c69e83a3-5217-ab76-e053-2995a90ae7c0	2
198148	prednisone 50 MG Oral Tablet	SCD	c69e83a3-5217-ab76-e053-2995a90ae7c0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-246-07	72189024607	7 TABLET in 1 BOTTLE (72189-246-07)	7 tablet	2021-07-08	0000-00-00	No	No	Current