Prednisone

Product NDC: 67296-0138
11-digit product format: 672960138
Labeler code: 67296
Product ID: 67296-0138_d5fbe823-eb10-76fa-e053-2a95a90ae7b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA085161
Marketing category: ANDA
Marketing start: 1990-01-01
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 20 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67296-0138		I	Inactivated by FDA	2026-08-17
excluded package	package	67296-0138	67296-0138-1	I	Inactivated by FDA	2026-08-17
excluded package	package	67296-0138	67296-0138-2	I	Inactivated by FDA	2026-08-17
excluded package	package	67296-0138	67296-0138-3	I	Inactivated by FDA	2026-08-17
excluded package	package	67296-0138	67296-0138-4	I	Inactivated by FDA	2026-08-17

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	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-0138-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-0138-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-0138-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-0138-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-0138-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-0138-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-0138-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-0138-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-0138-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-0138-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-0138-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-0138-3	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A085161-001	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A085161-001	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 · 42 observed 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
2026-08-18 06:07:40	2026-07	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A085161-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085161-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085161-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085161-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085161-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085161-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085161-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085161-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085161-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085161-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085161-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085161-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085161-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085161-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085161-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085161-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085161-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085161-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085161-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085161-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085161-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085161-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085161-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085161-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085161-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085161-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085161-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085161-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085161-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085161-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085161-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085161-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085161-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085161-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085161-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085161-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085161-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085161-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085161-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085161-001	AB	1	`e64feba35796…`

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
67296-0138-1	2026-01-29	PredniSONE Tablets, USP Revised: October 2015 Rx Only
67296-0138-2	2026-01-29	PredniSONE Tablets, USP Revised: October 2015 Rx Only
67296-0138-3	2026-01-29	PredniSONE Tablets, USP Revised: October 2015 Rx Only
67296-0138-4	2026-01-29	PredniSONE Tablets, USP Revised: October 2015 Rx Only
67296-0138-1	2024-06-03	PredniSONE Tablets, USP Revised: October 2015 Rx Only
67296-0138-2	2024-06-03	PredniSONE Tablets, USP Revised: October 2015 Rx Only
67296-0138-3	2024-06-03	PredniSONE Tablets, USP Revised: October 2015 Rx Only
67296-0138-4	2024-06-03	PredniSONE Tablets, USP Revised: October 2015 Rx Only
67296-0138-1	2024-01-30	PredniSONE Tablets, USP Revised: October 2015 Rx Only
67296-0138-2	2024-01-30	PredniSONE Tablets, USP Revised: October 2015 Rx Only
67296-0138-3	2024-01-30	PredniSONE Tablets, USP Revised: October 2015 Rx Only
67296-0138-4	2024-01-30	PredniSONE Tablets, USP Revised: October 2015 Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67296-0138-1	Prednisone	10 in 1 BOTTLE	TABLET	10	8
67296-0138-2	Prednisone	15 in 1 BOTTLE	TABLET	15	8
67296-0138-3	Prednisone	20 in 1 BOTTLE	TABLET	20	8
67296-0138-4	Prednisone	30 in 1 BOTTLE	TABLET	30	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0138	PREDNISONE TABLET [REDPHARM DRUG, INC.]	8	Legacy NDC, 4 package rows	20240621_81695f4d-b975-691e-e053-2991aa0a5d63.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	A-S Medication Solutions	aaaa3460-0239-4203-857f-0ada303c2108	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161
Prednisone	PREDNISONE	A-S Medication Solutions	de498de3-6ee6-4594-895e-cc69f050e34e	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161
Prednisone	PREDNISONE	A-S Medication Solutions	a6811c1f-3dad-46bb-b541-fddd2ff8e569	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161
Prednisone	PREDNISONE	Northwind Health Company, LLC	f6cb7924-4190-f130-e053-6294a90a21fe	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161
Prednisone	PREDNISONE	QPharma, Inc.	d898d53f-c7d2-4bdb-bd9e-5f200070d123	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161
Prednisone	PREDNISONE	Actavis Pharma, Inc.	aa0b1582-6ef3-4697-9ea6-5391e6e57853	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	7e541478-4a33-189f-e053-2a91aa0a6962	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161
Prednisone	PREDNISONE	Proficient Rx LP	016d65c3-fff2-4e0c-9025-e2083cfa6a1f	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161

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
312615	predniSONE 20 MG Oral Tablet	PSN	81695f4d-b975-691e-e053-2991aa0a5d63	8
312615	prednisone 20 MG Oral Tablet	SCD	81695f4d-b975-691e-e053-2991aa0a5d63	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-0138-1	67296013801	10 TABLET in 1 BOTTLE (67296-0138-1)	10 tablet	2019-01-01	0000-00-00	No	No	Current
67296-0138-2	67296013802	15 TABLET in 1 BOTTLE (67296-0138-2)	15 tablet	2019-01-01	0000-00-00	No	No	Current
67296-0138-3	67296013803	20 TABLET in 1 BOTTLE (67296-0138-3)	20 tablet	1990-01-01	0000-00-00	No	No	Current
67296-0138-4	67296013804	30 TABLET in 1 BOTTLE (67296-0138-4)	30 tablet	1990-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP Revised: October 2015 Rx Only	RedPharm Drug, Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	8