Prednisone

Product NDC: 59746-175
Requested package NDC: 59746-175-10
11-digit product format: 597460175
Labeler code: 59746
Product ID: 59746-175_3b1247fb-3a8d-4c94-b26a-a61398316cc3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: JUBILANT CADISTA PHARMACEUTICALS INC.
Application: ANDA040362
Marketing category: ANDA
Marketing start: 2001-08-29
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 20 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	59746-175	59746-175-10	D	Discontinued by firm		2026-08-03

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	TE codes	Approval date
A040362-001	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29
A040362-002	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29
A040362-003	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29
A040362-004	PREDNISONE	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17
A040362-005	PREDNISONE	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A040362-001	AB
A040362-002	AB
A040362-003	AB
A040362-004	AB
A040362-005	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 5 · 167 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
2026-02-19 14:30 UTC	2026-02	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-001	PREDNISONE	10MG	TABLET / ORAL	AB	2001-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-002	PREDNISONE	5MG	TABLET / ORAL	AB	2001-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-003	PREDNISONE	20MG	TABLET / ORAL	AB	2005-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2023-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-005	PREDNISONE	50MG	TABLET / ORAL	AB	2023-04-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 167 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040362-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040362-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040362-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040362-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040362-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040362-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040362-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040362-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040362-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040362-005	AB	1	`5bbf6a4d5a75…`

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
59746-175-06	EA - Each	59746-175	be403b3c-57b9-4a47-8da4-d6cabb3f4fc6	1	2012-07-24
59746-175-09	EA - Each	59746-175	bc0e729c-216f-4cb6-a783-ca2189f3102b	1	2012-07-24
59746-175-10	EA - Each	59746-175	7fc26b50-3348-40ca-9ae5-c5dac08d6e42	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.]	3
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [SAFECOR HEALTH, LLC]	3
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [SAFECOR HEALTH, LLC]	3
Prednisone	ACTIVE MOIETY	VB0R961HZT	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	PREDNISONE TABLET [SAFECOR HEALTH, LLC]	3
Fd&c Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [SAFECOR HEALTH, LLC]	3
Fd&c Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [SAFECOR HEALTH, LLC]	3
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [SAFECOR HEALTH, LLC]	3
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	PREDNISONE TABLET [SAFECOR HEALTH, LLC]	3
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [SAFECOR HEALTH, LLC]	3
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Starch, Potato	INACTIVE INGREDIENT	8I089SAH3T	PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Starch, Potato	INACTIVE INGREDIENT	8I089SAH3T	PREDNISONE TABLET [SAFECOR HEALTH, LLC]	3
Prednisone	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
Prednisone	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
Fd&c Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
Starch, Potato	INACTIVE INGREDIENT	8I089SAH3T	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-175	PREDNISONE TABLET PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	9	Legacy NDC	20240526_931ceb82-23b9-46c6-a00b-4cd66ed6f88f.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	A-S Medication Solutions	74102cc5-7a1a-4a0f-a07f-a4b0f86bcabf	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	A-S Medication Solutions	dc94273f-af06-4bd5-9ce3-ce0a0f36587b	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	af863b9e-964b-3b1e-e053-2995a90ab93a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Advanced Rx Pharmacy of Tennessee, LLC	b3dbf833-b929-8c85-e053-2995a90a5896	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Advanced Rx Pharmacy of Tennessee, LLC	e1e7d14b-80b2-f57e-e053-2995a90af112	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Advanced Rx Pharmacy of Tennessee, LLC	b3dbff9f-610f-7782-e053-2a95a90a71c1	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	62fdf3c2-cfa9-d573-e053-2a91aa0a833b	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	62ec965c-e682-9920-e053-2a91aa0adcdb	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	62ff1da3-79aa-676a-e053-2991aa0a4a9f	2024-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	A-S Medication Solutions	751b7f62-f92b-4b7c-a588-2c882d5d1ce3	2024-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	A-S Medication Solutions	cb1b0dc0-6916-4e6f-9775-26ea0f593f83	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	63106192-35d5-6989-e053-2991aa0aa714	2024-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	A-S Medication Solutions	5c8ffc9d-3804-40d3-ae2c-1fbac7bdc8d2	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	63102d75-9b2b-84a9-e053-2a91aa0a317d	2024-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Proficient Rx LP	5961b1d4-6a4c-452f-b3f1-c99f3a9a6445	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Asclemed USA, Inc.	dc663fd3-b149-48ae-a3f3-6abaa4808cc6	2020-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Proficient Rx LP	e4555299-af68-416f-8999-9bb703a45e77	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362
Prednisone	PREDNISONE	Proficient Rx LP	7c650dc8-43f6-4257-81ed-c93b00202d06	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040362 application number: ANDA040362

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	dc94273f-af06-4bd5-9ce3-ce0a0f36587b	22
312615	predniSONE 20 MG Oral Tablet	PSN	dc94273f-af06-4bd5-9ce3-ce0a0f36587b	22
198145	prednisone 10 MG Oral Tablet	SCD	dc94273f-af06-4bd5-9ce3-ce0a0f36587b	22
312615	prednisone 20 MG Oral Tablet	SCD	dc94273f-af06-4bd5-9ce3-ce0a0f36587b	22
312615	predniSONE 20 MG Oral Tablet	PSN	751b7f62-f92b-4b7c-a588-2c882d5d1ce3	21
312617	predniSONE 5 MG Oral Tablet	PSN	751b7f62-f92b-4b7c-a588-2c882d5d1ce3	21
312615	prednisone 20 MG Oral Tablet	SCD	751b7f62-f92b-4b7c-a588-2c882d5d1ce3	21
312617	prednisone 5 MG Oral Tablet	SCD	751b7f62-f92b-4b7c-a588-2c882d5d1ce3	21
198145	predniSONE 10 MG Oral Tablet	PSN	70003b50-1802-436d-9bee-3e2e4858e461	15
312615	predniSONE 20 MG Oral Tablet	PSN	70003b50-1802-436d-9bee-3e2e4858e461	15
312617	predniSONE 5 MG Oral Tablet	PSN	70003b50-1802-436d-9bee-3e2e4858e461	15
198145	prednisone 10 MG Oral Tablet	SCD	70003b50-1802-436d-9bee-3e2e4858e461	15
312615	prednisone 20 MG Oral Tablet	SCD	70003b50-1802-436d-9bee-3e2e4858e461	15
312617	prednisone 5 MG Oral Tablet	SCD	70003b50-1802-436d-9bee-3e2e4858e461	15
198145	predniSONE 10 MG Oral Tablet	PSN	bcc8c648-fc70-44e8-9acc-cdf893097a38	8
312615	predniSONE 20 MG Oral Tablet	PSN	bcc8c648-fc70-44e8-9acc-cdf893097a38	8
312615	predniSONE 20 MG Oral Tablet	PSN	62fdf3c2-cfa9-d573-e053-2a91aa0a833b	8
198145	prednisone 10 MG Oral Tablet	SCD	bcc8c648-fc70-44e8-9acc-cdf893097a38	8
312615	prednisone 20 MG Oral Tablet	SCD	62fdf3c2-cfa9-d573-e053-2a91aa0a833b	8
312615	prednisone 20 MG Oral Tablet	SCD	bcc8c648-fc70-44e8-9acc-cdf893097a38	8
312615	predniSONE 20 MG Oral Tablet	PSN	b3dbff9f-610f-7782-e053-2a95a90a71c1	7
312615	prednisone 20 MG Oral Tablet	SCD	b3dbff9f-610f-7782-e053-2a95a90a71c1	7
312615	predniSONE 20 MG Oral Tablet	PSN	62ff1da3-79aa-676a-e053-2991aa0a4a9f	6
312615	predniSONE 20 MG Oral Tablet	PSN	4e7a8c58-2da2-2f87-e054-00144ff88e88	6
312615	predniSONE 20 MG Oral Tablet	PSN	e4555299-af68-416f-8999-9bb703a45e77	6
312615	prednisone 20 MG Oral Tablet	SCD	62ff1da3-79aa-676a-e053-2991aa0a4a9f	6
312615	prednisone 20 MG Oral Tablet	SCD	4e7a8c58-2da2-2f87-e054-00144ff88e88	6
312615	prednisone 20 MG Oral Tablet	SCD	e4555299-af68-416f-8999-9bb703a45e77	6
198145	predniSONE 10 MG Oral Tablet	PSN	1418d2f2-07d5-407a-81ca-380a5615b5b4	5
312615	predniSONE 20 MG Oral Tablet	PSN	1418d2f2-07d5-407a-81ca-380a5615b5b4	5
312617	predniSONE 5 MG Oral Tablet	PSN	1418d2f2-07d5-407a-81ca-380a5615b5b4	5
198145	prednisone 10 MG Oral Tablet	SCD	1418d2f2-07d5-407a-81ca-380a5615b5b4	5
312615	prednisone 20 MG Oral Tablet	SCD	1418d2f2-07d5-407a-81ca-380a5615b5b4	5
312617	prednisone 5 MG Oral Tablet	SCD	1418d2f2-07d5-407a-81ca-380a5615b5b4	5
198145	predniSONE 10 MG Oral Tablet	PSN	dd933616-6988-4535-96b1-3c26d4432536	4
312615	predniSONE 20 MG Oral Tablet	PSN	dd933616-6988-4535-96b1-3c26d4432536	4
312617	predniSONE 5 MG Oral Tablet	PSN	dd933616-6988-4535-96b1-3c26d4432536	4
198145	prednisone 10 MG Oral Tablet	SCD	dd933616-6988-4535-96b1-3c26d4432536	4
312615	prednisone 20 MG Oral Tablet	SCD	dd933616-6988-4535-96b1-3c26d4432536	4
312617	prednisone 5 MG Oral Tablet	SCD	dd933616-6988-4535-96b1-3c26d4432536	4
198145	predniSONE 10 MG Oral Tablet	PSN	dc663fd3-b149-48ae-a3f3-6abaa4808cc6	1
312615	predniSONE 20 MG Oral Tablet	PSN	f617ee81-20ff-4c3e-b3af-40a3842bddbf	1
312615	predniSONE 20 MG Oral Tablet	PSN	83e76d04-cba2-5aee-e053-2a91aa0add6a	1
312615	predniSONE 20 MG Oral Tablet	PSN	3f4f6272-e051-41f0-a1a1-7abfcc3aa884	1
312615	predniSONE 20 MG Oral Tablet	PSN	dc663fd3-b149-48ae-a3f3-6abaa4808cc6	1
312617	predniSONE 5 MG Oral Tablet	PSN	dc663fd3-b149-48ae-a3f3-6abaa4808cc6	1
198145	prednisone 10 MG Oral Tablet	SCD	dc663fd3-b149-48ae-a3f3-6abaa4808cc6	1
312615	prednisone 20 MG Oral Tablet	SCD	3f4f6272-e051-41f0-a1a1-7abfcc3aa884	1
312615	prednisone 20 MG Oral Tablet	SCD	dc663fd3-b149-48ae-a3f3-6abaa4808cc6	1
312615	prednisone 20 MG Oral Tablet	SCD	f617ee81-20ff-4c3e-b3af-40a3842bddbf	1
312615	prednisone 20 MG Oral Tablet	SCD	83e76d04-cba2-5aee-e053-2a91aa0add6a	1
312617	prednisone 5 MG Oral Tablet	SCD	dc663fd3-b149-48ae-a3f3-6abaa4808cc6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59746-175-10	59746017510	1000 TABLET in 1 BOTTLE (59746-175-10)	1000 tablet	2001-08-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	24
PREDNISONE	Direct_Rx	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	8
PredniSONE Tablets, USP Rx only	REMEDYREPACK INC.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	16
PredniSONE Tablets, USP Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	6
PredniSONE Tablets, USP Rx only	QPharma, Inc. \| Northwind Health Company, LLC	2025-12-01	HUMAN PRESCRIPTION DRUG LABEL	4
PredniSONE Tablets, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-09-25	HUMAN PRESCRIPTION DRUG LABEL	19
PredniSONE Tablets, USP Rx only	Bryant Ranch Prepack	2025-09-05	HUMAN PRESCRIPTION DRUG LABEL	11
PredniSONE Tablets, USP Rx only	Jubilant Cadista Pharmacuticals Inc. \| Jubilant Cadista Pharmaceuticals In	2025-07-14	Human Prescription Drug Label	10
PredniSONE Tablets, USP Rx only	A-S Medication Solutions	2025-07-03	HUMAN PRESCRIPTION DRUG LABEL	22
PredniSONE Tablets, USP Rx only	Major Pharmaceuticals	2025-01-16	HUMAN PRESCRIPTION DRUG LABEL	4
PredniSONE Tablets, USP Rx only	REMEDYREPACK INC.	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	15
Prednisone Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	7
PredniSONE Tablets, USP Rx only	Quality Care Products LLC	2024-12-16	HUMAN PRESCRIPTION DRUG LABEL	15
PredniSONE Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	8
PredniSONE Tablets, USP Rx only	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	15
PredniSONE Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2024-07-19	HUMAN PRESCRIPTION DRUG LABEL	6
Prednisone - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL	6
PredniSONE Tablets, USP Rx only	Bryant Ranch Prepack	2024-07-08	HUMAN PRESCRIPTION DRUG LABEL	103
PredniSONE Tablets, USP Rx only	A-S Medication Solutions	2024-06-25	HUMAN PRESCRIPTION DRUG LABEL	21
PredniSONE Tablets, USP 20mg Rx only	Pharmasource Meds, LLC	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	3
PredniSONE Tablets, USP Rx only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	8
PredniSONE Tablets, USP Rx only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	9
PredniSONE Tablets, USP Rx only	St. Mary's Medical Park Pharmacy	2022-12-08	HUMAN PRESCRIPTION DRUG LABEL	4
PredniSONE Tablets, USP Rx only	Bryant Ranch Prepack	2021-11-16	HUMAN PRESCRIPTION DRUG LABEL	7
PredniSONE Tablets, USP Rx only	Preferred Pharmaceuticals, Inc.	2021-08-31	HUMAN PRESCRIPTION DRUG LABEL	6