Prednisone

Product NDC: 67296-0140
Requested package NDC: 67296-0140-2
11-digit product format: 672960140
Labeler code: 67296
Product ID: 67296-0140_d5fbea2f-f34e-900f-e053-2995a90a3887
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug Inc.
Application: ANDA085162
Marketing category: ANDA
Marketing start: 1987-11-01
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 10 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-0140	67296-0140-2	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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	`110d247fa046…`	`a55b01930146…`

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
A085162-001	PREDNISONE	PREDNISONE	10MG	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
A085162-001	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	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085162-001	PREDNISONE	10MG	TABLET / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085162-001	PREDNISONE	10MG	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	A085162-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085162-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085162-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085162-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085162-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085162-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085162-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085162-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085162-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085162-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085162-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085162-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085162-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085162-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085162-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085162-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085162-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085162-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085162-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085162-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085162-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085162-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085162-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085162-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085162-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085162-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085162-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085162-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085162-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085162-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085162-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085162-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085162-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085162-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085162-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085162-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085162-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085162-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085162-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085162-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Prednisone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISONE	10 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
198145	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
5407a00b-1bfb-e37d-e063-6294a90a6c41	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
67296-0140-1	2026-01-29	Prednisone 10mg
67296-0140-2	2026-01-29	Prednisone 10mg
67296-0140-3	2026-01-29	Prednisone 10mg
67296-0140-9	2026-01-29	Prednisone 10mg
67296-0140-1	2024-06-20	Prednisone 10mg
67296-0140-2	2024-06-20	Prednisone 10mg
67296-0140-3	2024-06-20	Prednisone 10mg
67296-0140-9	2024-06-20	Prednisone 10mg
67296-0140-1	2024-01-30	Prednisone 10mg
67296-0140-2	2024-01-30	Prednisone 10mg
67296-0140-3	2024-01-30	Prednisone 10mg
67296-0140-9	2024-01-30	Prednisone 10mg
67296-0140-2	2020-04-22	Prednisone 10mg
67296-0140-2	2019-10-29	Prednisone 10mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67296-0140-1	Prednisone	10 in 1 BOTTLE	TABLET	10	5
67296-0140-2	Prednisone	30 in 1 BOTTLE	TABLET	30	5
67296-0140-3	Prednisone	42 in 1 BOTTLE	TABLET	42	5
67296-0140-9	Prednisone	9 in 1 BOTTLE	TABLET	9	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [REDPHARM DRUG INC.]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [REDPHARM DRUG INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PREDNISONE TABLET [REDPHARM DRUG INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [REDPHARM DRUG INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PREDNISONE TABLET [REDPHARM DRUG INC.]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	PREDNISONE TABLET [REDPHARM DRUG INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [REDPHARM DRUG INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PREDNISONE TABLET [REDPHARM DRUG INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0140	PREDNISONE TABLET [REDPHARM DRUG INC.]	5	Legacy NDC, 4 package rows	20240621_c8bc83d5-b9e2-4d31-a3df-8e899aac1ba5.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Redpharm Drug	5407a00b-1bfb-e37d-e063-6294a90a6c41	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085162 application number: ANDA085162 ndc (product): 67296-0140
Prednisone D/P	PREDNISONE D/P	Direct_Rx	41ade439-59f2-dfd1-e063-6294a90aca0f	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085162 application number: ANDA085162
Prednisone	PREDNISONE	Northwind Health Company, LLC	0f377d9f-b2f4-4dae-b503-5f963bea281f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085162 application number: ANDA085162
Prednisone	PREDNISONE	QPharma, Inc.	07fb8daa-2ceb-4564-b0d0-6cdf903da0b5	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085162 application number: ANDA085162
Prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	309580a7-c3bb-e53b-e063-6394a90a1563	2025-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085162 application number: ANDA085162
Prednisone	PREDNISONE	Actavis Pharma, Inc.	aa0b1582-6ef3-4697-9ea6-5391e6e57853	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085162 application number: ANDA085162
Prednisone	PREDNISONE	Proficient Rx LP	94f8ec56-667e-4eda-832d-f2936f12dc36	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085162 application number: ANDA085162

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
198145	predniSONE 10 MG Oral Tablet	PSN	c8bc83d5-b9e2-4d31-a3df-8e899aac1ba5	5
198145	prednisone 10 MG Oral Tablet	SCD	c8bc83d5-b9e2-4d31-a3df-8e899aac1ba5	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-0140-2	67296014002	30 TABLET in 1 BOTTLE (67296-0140-2)	30 tablet	2011-06-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
predniSONE Tablets, USP Rx only	Redpharm Drug	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	1
Prednisone 10mg	RedPharm Drug Inc. \| RedPharm Drug, Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	5