PredniSONE

Product NDC: 67296-1194
11-digit product format: 672961194
Labeler code: 67296
Product ID: 67296-1194_d610062d-3992-dec3-e053-2995a90a9ca1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PredniSONE
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA084283
Marketing category: ANDA
Marketing start: 2003-03-14
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 50 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	67296-1194		I	Inactivated by FDA	2026-10-05
excluded package	package	67296-1194	67296-1194-3	I	Inactivated by FDA	2026-10-05
excluded package	package	67296-1194	67296-1194-5	I	Inactivated by FDA	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 · 15 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
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1194-3	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1194-5	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1194-3	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1194-5	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1194-3	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1194-5	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1194-3	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1194-5	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-1194-3	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-1194-5	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084283-001	PREDNISONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084283-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084283-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084283-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084283-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084283-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084283-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084283-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084283-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084283-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084283-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084283-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084283-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084283-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084283-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084283-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084283-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084283-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084283-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084283-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084283-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084283-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084283-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084283-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084283-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084283-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084283-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084283-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084283-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084283-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084283-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084283-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084283-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084283-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084283-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084283-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084283-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084283-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

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, Related label table
NDC	Effective	Related label
67296-1194-3	2026-01-29	4ecb7106-afbf-01a7-e054-00144ff8d46c
67296-1194-5	2026-01-29	4ecb7106-afbf-01a7-e054-00144ff8d46c
67296-1194-3	2024-07-15	4ecb7106-afbf-01a7-e054-00144ff8d46c
67296-1194-5	2024-07-15	4ecb7106-afbf-01a7-e054-00144ff8d46c
67296-1194-3	2024-01-30	4ecb7106-afbf-01a7-e054-00144ff8d46c
67296-1194-5	2024-01-30	4ecb7106-afbf-01a7-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1194-3	PredniSONE	3 in 1 BOTTLE	TABLET	3		4
67296-1194-5	PredniSONE	5 in 1 BOTTLE	TABLET	5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1194	PREDNISONE TABLET [REDPHARM DRUG, INC.]	4	Legacy NDC, 2 package rows	20240716_4ecb7106-afbf-01a7-e054-00144ff8d46c.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PredniSONE	PREDNISONE	Northwind Health Company, LLC	f77f4a5a-b307-84ff-e053-6294a90aba5b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084283 application number: ANDA084283
PredniSONE	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	5b2f4fa9-817c-43c9-ac9a-750ab1d1f66f	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084283 application number: ANDA084283
PredniSONE	PREDNISONE	Proficient Rx LP	e109f428-ca85-4a2c-acd0-ca8d498e7723	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084283 application number: ANDA084283

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
198148	predniSONE 50 MG Oral Tablet	PSN	4ecb7106-afbf-01a7-e054-00144ff8d46c	4
198148	prednisone 50 MG Oral Tablet	SCD	4ecb7106-afbf-01a7-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1194-3	67296119403	3 TABLET in 1 BOTTLE (67296-1194-3)	3 tablet	2003-03-14	0000-00-00	No	No	Current
67296-1194-5	67296119405	5 TABLET in 1 BOTTLE (67296-1194-5)	5 tablet	2003-03-14	0000-00-00	No	No	Current