PredniSONE

Product NDC: 0054-0017
11-digit product format: 000540017
Labeler code: 0054
Product ID: 0054-0017_523ad364-8d95-4679-9290-446d61f36eb5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PredniSONE
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA080352
Marketing category: ANDA
Marketing start: 2003-02-13
Substance: PREDNISONE
Active strength: 10 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080352-001	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A080352-002	PREDNISONE	PREDNISONE	1MG	TABLET / ORAL	AB	RLD, RS	1982-04-22
A080352-003	PREDNISONE	PREDNISONE	2.5MG	TABLET / ORAL	AB	RLD, RS	1982-04-22
A080352-004	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A080352-005	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A080352-006	PREDNISONE	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A080352-001	AB
A080352-002	AB
A080352-003	AB
A080352-004	AB
A080352-005	AB
A080352-006	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 · 61 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-002	PREDNISONE	1MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-003	PREDNISONE	2.5MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-004	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-005	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-006	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-002	PREDNISONE	1MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-003	PREDNISONE	2.5MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-004	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-005	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-006	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-002	PREDNISONE	1MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-003	PREDNISONE	2.5MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-004	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-005	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-006	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`3f01610625f2…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 61 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	A080352-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080352-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080352-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080352-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080352-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080352-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080352-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080352-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080352-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080352-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080352-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080352-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080352-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080352-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080352-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080352-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080352-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080352-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080352-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080352-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080352-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080352-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080352-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080352-001	AB	1	`3f01610625f2…`

Additional Listing Data#

Finished product: Yes
Brand name base: PredniSONE
Listing expiration: 2026-12-31

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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198144	Internal RxNorm lookup
198145	Internal RxNorm lookup
198146	Internal RxNorm lookup
198148	Internal RxNorm lookup
205301	Internal RxNorm lookup
312615	Internal RxNorm lookup
312617	Internal RxNorm lookup
315187	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
3115aef0-fd50-4ec8-a064-3effb695f3f2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
2205d503-be51-445b-bb34-c209cc557b3c	Product name	5	20230105
9492a99d-61c8-491f-9086-1c6a7e98c040	Product name	6	20230105
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
205c2cdd-a63b-cbc9-6bcb-6be6001edf81	Product name	2	20170705
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0054-0017-20	2022-08-04	PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)
0054-0017-25	2022-08-04	PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)
0054-0017-29	2022-08-04	PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)
0054-0017-20	2022-07-29	PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)
0054-0017-25	2022-07-29	PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)
0054-0017-29	2022-07-29	PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0054-0017-20	PredniSONE	10 in 1 CARTON	TABLET	10	24
0054-0017-20	PredniSONE	10 in 1 BLISTER PACK	TABLET	10	24
0054-0017-25	PredniSONE	100 in 1 BOTTLE, PLASTIC	TABLET	100	24
0054-0017-29	PredniSONE	500 in 1 BOTTLE, PLASTIC	TABLET	500	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0017-20	EA - Each	0054-0017	fd276678-e361-49b3-9b17-cc8184dd8ae0	1	2012-07-24
0054-0017-25	EA - Each	0054-0017	a1de34e1-b874-4bbb-a255-985154e652c5	1	2012-07-24
0054-0017-29	EA - Each	0054-0017	b17fb088-bf43-476a-91fb-f463f2a1ff14	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	13
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	13
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	13
SODIUM GLYCOLATE	INACTIVE INGREDIENT	B75E535IMI	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	13
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	13
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]	13
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [CARDINAL HEALTH]	8
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [CARDINAL HEALTH]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [CARDINAL HEALTH]	8
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PREDNISONE TABLET [CARDINAL HEALTH]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [CARDINAL HEALTH]	8
SODIUM GLYCOLATE	INACTIVE INGREDIENT	B75E535IMI	PREDNISONE TABLET [CARDINAL HEALTH]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [CARDINAL HEALTH]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [CARDINAL HEALTH]	8
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PREDNISONE TABLET [CARDINAL HEALTH]	8
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
FRUCTOSE	INACTIVE INGREDIENT	6YSS42VSEV	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
MALTOL	INACTIVE INGREDIENT	3A9RD92BS4	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
SODIUM GLYCOLATE	INACTIVE INGREDIENT	B75E535IMI	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]	7
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.]	6
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.]	6
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.]	6
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM GLYCOLATE	INACTIVE INGREDIENT	B75E535IMI	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0017	PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.]	23	Current NDC, Legacy NDC, 4 package rows	20240308_3115aef0-fd50-4ec8-a064-3effb695f3f2.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PredniSONE	PREDNISONE	St. Mary's Medical Park Pharmacy	16ee689e-c7a9-3a5a-e063-6394a90a6ea2	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	Northwind Health Company, LLC	ab315be2-8d13-be25-e053-2995a90a5184	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	Northwind Health Company, LLC	c9f4711d-319c-d952-e053-2a95a90a3697	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	REMEDYREPACK INC.	7db793b4-5768-4e9a-a47b-1ebbfed74001	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	f4500eb6-d24a-4247-83f4-99e73346e328	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	Hikma Pharmaceuticals USA Inc.	263ed4fa-3c29-4abb-9cb1-bc016bd34a05	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	Hikma Pharmaceuticals USA Inc.	3115aef0-fd50-4ec8-a064-3effb695f3f2	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352 ndc (product): 0054-0017
PredniSONE	PREDNISONE	Advanced Rx of Tennessee, LLC	2e62cf2e-dcbe-c15e-e063-6294a90a8168	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	Advanced Rx of Tennessee, LLC	2e630aa1-eccd-f5eb-e063-6294a90a4745	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
Prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	af861c38-3293-13fe-e053-2995a90a9932	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	NuCare Pharmaceuticals,Inc.	1289c6d2-2707-baca-e063-6294a90a750d	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	A-S Medication Solutions	0060b86b-0b79-4c54-a7be-97683a933a05	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	A-S Medication Solutions	f11c190e-edf8-454d-82c4-1ed769b5a6d2	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	A-S Medication Solutions	6f0719a2-1759-4354-9363-bb9fb3bddb3d	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352

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	5b2f4fa9-817c-43c9-ac9a-750ab1d1f66f	25
198145	prednisone 10 MG Oral Tablet	SCD	5b2f4fa9-817c-43c9-ac9a-750ab1d1f66f	25
198144	predniSONE 1 MG Oral Tablet	PSN	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
198145	predniSONE 10 MG Oral Tablet	PSN	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
198146	predniSONE 2.5 MG Oral Tablet	PSN	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
312615	predniSONE 20 MG Oral Tablet	PSN	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
205301	predniSONE 5 MG in 1 mL Concentrate for Oral Solution	PSN	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
315187	predniSONE 5 MG in 5 mL Oral Solution	PSN	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
312617	predniSONE 5 MG Oral Tablet	PSN	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
198148	predniSONE 50 MG Oral Tablet	PSN	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
198144	prednisone 1 MG Oral Tablet	SCD	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
315187	prednisone 1 MG/ML Oral Solution	SCD	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
198145	prednisone 10 MG Oral Tablet	SCD	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
198146	prednisone 2.5 MG Oral Tablet	SCD	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
312615	prednisone 20 MG Oral Tablet	SCD	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
312617	prednisone 5 MG Oral Tablet	SCD	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
205301	prednisone 5 MG/ML Oral Solution	SCD	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
198148	prednisone 50 MG Oral Tablet	SCD	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
205301	prednisone 5 MG per 1 ML Concentrate for Oral Solution	SY	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
315187	prednisone 5 MG per 5 ML Oral Solution	SY	3115aef0-fd50-4ec8-a064-3effb695f3f2	24
198144	predniSONE 1 MG Oral Tablet	PSN	3b0fd893-75f6-44e6-9a8b-ec5c2f0a2828	13
198145	predniSONE 10 MG Oral Tablet	PSN	3b0fd893-75f6-44e6-9a8b-ec5c2f0a2828	13
312615	predniSONE 20 MG Oral Tablet	PSN	3b0fd893-75f6-44e6-9a8b-ec5c2f0a2828	13
312617	predniSONE 5 MG Oral Tablet	PSN	3b0fd893-75f6-44e6-9a8b-ec5c2f0a2828	13
198148	predniSONE 50 MG Oral Tablet	PSN	3b0fd893-75f6-44e6-9a8b-ec5c2f0a2828	13
198144	prednisone 1 MG Oral Tablet	SCD	3b0fd893-75f6-44e6-9a8b-ec5c2f0a2828	13
198145	prednisone 10 MG Oral Tablet	SCD	3b0fd893-75f6-44e6-9a8b-ec5c2f0a2828	13
312615	prednisone 20 MG Oral Tablet	SCD	3b0fd893-75f6-44e6-9a8b-ec5c2f0a2828	13
312617	prednisone 5 MG Oral Tablet	SCD	3b0fd893-75f6-44e6-9a8b-ec5c2f0a2828	13
198148	prednisone 50 MG Oral Tablet	SCD	3b0fd893-75f6-44e6-9a8b-ec5c2f0a2828	13
198145	predniSONE 10 MG Oral Tablet	PSN	318fdf0d-c03a-4b48-a380-b7bb630363fb	6
198145	prednisone 10 MG Oral Tablet	SCD	318fdf0d-c03a-4b48-a380-b7bb630363fb	6
198145	predniSONE 10 MG Oral Tablet	PSN	dad4f191-8893-48e0-e053-2995a90ae864	4
198145	prednisone 10 MG Oral Tablet	SCD	dad4f191-8893-48e0-e053-2995a90ae864	4
198144	predniSONE 1 MG Oral Tablet	PSN	ee0621e8-fecd-4b9e-9e1b-91a4abf22bdb	3
198145	predniSONE 10 MG Oral Tablet	PSN	ee0621e8-fecd-4b9e-9e1b-91a4abf22bdb	3
198144	prednisone 1 MG Oral Tablet	SCD	ee0621e8-fecd-4b9e-9e1b-91a4abf22bdb	3
198145	prednisone 10 MG Oral Tablet	SCD	ee0621e8-fecd-4b9e-9e1b-91a4abf22bdb	3
198145	predniSONE 10 MG Oral Tablet	PSN	e23a0f1e-e8ff-4be2-a74f-bc54cd44b3db	2
198145	prednisone 10 MG Oral Tablet	SCD	e23a0f1e-e8ff-4be2-a74f-bc54cd44b3db	2
198145	predniSONE 10 MG Oral Tablet	PSN	116acf2b-e610-0e90-e054-00144ff88e88	1
312615	predniSONE 20 MG Oral Tablet	PSN	116acf2b-e610-0e90-e054-00144ff88e88	1
198145	prednisone 10 MG Oral Tablet	SCD	116acf2b-e610-0e90-e054-00144ff88e88	1
312615	prednisone 20 MG Oral Tablet	SCD	116acf2b-e610-0e90-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0017-20	00054001720	10 BLISTER PACK in 1 CARTON (0054-0017-20) / 10 TABLET in 1 BLISTER PACK	10 blister pack	2003-02-13	0000-00-00	No	No	Current
0054-0017-25	00054001725	100 TABLET in 1 BOTTLE, PLASTIC (0054-0017-25)	100 tablet	2003-02-13	0000-00-00	No	No	Current
0054-0017-29	00054001729	500 TABLET in 1 BOTTLE, PLASTIC (0054-0017-29)	500 tablet	2003-02-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
PredniSONE Tablets, USP	QPharma, Inc. \| Hikma Pharmaceuticals USA Inc. \| Northwind Health Company, LLC	2025-12-05	HUMAN PRESCRIPTION DRUG LABEL	6
PredniSONE Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	25
PredniSONE Tablets, USP	Golden State Medical Supply, Inc.	2025-06-16	HUMAN PRESCRIPTION DRUG LABEL	11
PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2025-04-22	HUMAN PRESCRIPTION DRUG LABEL	24
PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)	Cardinal Health 107, LLC	2024-10-28	HUMAN PRESCRIPTION DRUG LABEL	26
PredniSONE Tablets USP PredniSONE Oral Solution USP PredniSONE Intensol ™ Oral Solution (Concentrate)	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Prednisone	NCS HealthCare of KY, LLC dba Vangard Labs	2021-03-10	HUMAN PRESCRIPTION DRUG LABEL	9
PredniSONE Tablets USP PredniSONE Oral Solution USP PredniSONE Intensol ™ Oral Solution (Concentrate)	Bryant Ranch Prepack	2020-10-12	HUMAN PRESCRIPTION DRUG LABEL	8
PredniSONE	Blenheim Pharmacal, Inc.	2015-03-16	HUMAN PRESCRIPTION DRUG LABEL	1
PredniSONE	Physicians Total Care, Inc.	2014-01-20	HUMAN PRESCRIPTION DRUG LABEL	13
PredniSONE Tablets USP, 1 mg, 10 mg	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-04-08	HUMAN PRESCRIPTION DRUG LABEL	3
PredniSONE	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-09-28	HUMAN PRESCRIPTION DRUG LABEL	2