PredniSONE

Product NDC: 0054-9818
11-digit product format: 000549818
Labeler code: 0054
Product ID: 0054-9818_249c4c6d-a058-489a-8f84-928c14bfd3f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PredniSONE
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA080352
Marketing category: ANDA
Marketing start: 2020-03-23
Substance: PREDNISONE
Active strength: 20 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 42.

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 · 67 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
2026-08-18 06:07:40	2026-07	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080352-002	PREDNISONE	1MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080352-003	PREDNISONE	2.5MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080352-004	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080352-005	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080352-006	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 67 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	A080352-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080352-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080352-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080352-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080352-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080352-006	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISONE	20 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198145	Internal RxNorm lookup
312615	Internal RxNorm lookup
312617	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
263ed4fa-3c29-4abb-9cb1-bc016bd34a05	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
0054-9818-25	2022-08-04	PredniSONE Tablets, USP
0054-9818-29	2022-08-04	PredniSONE Tablets, USP
0054-9818-25	2022-07-29	PredniSONE Tablets, USP
0054-9818-29	2022-07-29	PredniSONE Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-9818-25	PredniSONE	100 in 1 BOTTLE	TABLET	100		8
0054-9818-29	PredniSONE	500 in 1 BOTTLE	TABLET	500		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-9818	PREDNISONE TABLET [HIKMA PHARMACEUTICALS USA INC.]	7	Current NDC, Legacy NDC, 2 package rows	20250423_263ed4fa-3c29-4abb-9cb1-bc016bd34a05.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 ndc (product): 0054-9818
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
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	263ed4fa-3c29-4abb-9cb1-bc016bd34a05	8
312615	predniSONE 20 MG Oral Tablet	PSN	263ed4fa-3c29-4abb-9cb1-bc016bd34a05	8
312617	predniSONE 5 MG Oral Tablet	PSN	263ed4fa-3c29-4abb-9cb1-bc016bd34a05	8
198145	prednisone 10 MG Oral Tablet	SCD	263ed4fa-3c29-4abb-9cb1-bc016bd34a05	8
312615	prednisone 20 MG Oral Tablet	SCD	263ed4fa-3c29-4abb-9cb1-bc016bd34a05	8
312617	prednisone 5 MG Oral Tablet	SCD	263ed4fa-3c29-4abb-9cb1-bc016bd34a05	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-9818-25	00054981825	100 TABLET in 1 BOTTLE (0054-9818-25)	100 tablet	2020-03-23	0000-00-00	No	No	Current
0054-9818-29	00054981829	500 TABLET in 1 BOTTLE (0054-9818-29)	500 tablet	2020-03-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP	Hikma Pharmaceuticals USA Inc. \| Hikma Pharmaceuticals LLC	2025-04-22	HUMAN PRESCRIPTION DRUG LABEL	8