Prednisone

Product NDC: 59746-171
Requested package NDC: 59746-171-10
11-digit product format: 597460171
Labeler code: 59746
Product ID: 59746-171_a8972d19-5cd5-441c-a552-048116a069e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: JUBILANT CADISTA PHARMACEUTICALS INC.
Application: ANDA040611
Marketing category: ANDA
Marketing start: 2005-06-06
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 1 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	59746-171	59746-171-10	D	Discontinued by firm		2026-10-05

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
A040611-001	PREDNISONE	PREDNISONE	1MG	TABLET / ORAL	AB		2005-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040611-001	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	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`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	A040611-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040611-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040611-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040611-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040611-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040611-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040611-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040611-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040611-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040611-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040611-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040611-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040611-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040611-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040611-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040611-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040611-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040611-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040611-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040611-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040611-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040611-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040611-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040611-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040611-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040611-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040611-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040611-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040611-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040611-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040611-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040611-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040611-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040611-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040611-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040611-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040611-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040611-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040611-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040611-001	AB	1	`f41ea6bd6efb…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59746-171-06	EA - Each	59746-171	54c8ad35-6e14-49fe-b013-42336e71f09f	1	2012-07-24
59746-171-10	EA - Each	59746-171	70d197a6-24c6-45bd-b8f7-ec02cefbf675	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Prednisone	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	2
Prednisone	ACTIVE MOIETY	VB0R961HZT	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	2
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	2
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	2
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	2
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	2
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-171	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	4	Legacy NDC	20180703_e9d6774e-45f6-419f-b388-8dfb4dd34944.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Proficient Rx LP	7a92b171-52ca-4948-81fc-e9a30597c5d8	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040611 application number: ANDA040611

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	7a92b171-52ca-4948-81fc-e9a30597c5d8	3
198144	prednisone 1 MG Oral Tablet	SCD	7a92b171-52ca-4948-81fc-e9a30597c5d8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59746-171-10	59746017110	1000 TABLET in 1 BOTTLE (59746-171-10)	1000 tablet	2005-06-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP Rx Only	Bryant Ranch Prepack	2025-11-03	HUMAN PRESCRIPTION DRUG LABEL	101
PredniSONE Tablets, USP Rx Only	Bryant Ranch Prepack	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	102
PredniSONE Tablets, USP Rx Only	Jubilant Cadista Pharmacuticals Inc. \| Jubilant Cadista Pharmaceuticals In	2025-07-29	Human Prescription Drug Label	5
PredniSONE Tablets, USP Rx Only	Bryant Ranch Prepack	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	102
PredniSONE Tablets, USP Rx Only	REMEDYREPACK INC.	2020-05-19	HUMAN PRESCRIPTION DRUG LABEL	4
PredniSONE Tablets, USP Rx Only	Proficient Rx LP	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	3