PredniSONE

Product NDC: 68788-4182
Requested package NDC: 68788-4182-4
11-digit product format: 687884182
Labeler code: 68788
Product ID: 68788-4182_02158832-550b-4855-a5c5-6abbf13ed6f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PredniSONE
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA080352
Marketing category: ANDA
Marketing start: 2026-08-20
Substance: PREDNISONE
Active strength: 20 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 79 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
2026-10-15 13:18:30	2026-09	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A080352-002	PREDNISONE	1MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A080352-003	PREDNISONE	2.5MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A080352-004	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A080352-005	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A080352-006	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080352-002	PREDNISONE	1MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080352-003	PREDNISONE	2.5MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080352-004	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080352-005	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080352-006	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 79 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A080352-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A080352-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A080352-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A080352-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A080352-005	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A080352-006	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A080352-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080352-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080352-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080352-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080352-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080352-006	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312615	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
02158832-550b-4855-a5c5-6abbf13ed6f0	Available on FDA.report

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PredniSONE	PREDNISONE	REMEDYREPACK INC.	7db793b4-5768-4e9a-a47b-1ebbfed74001	2026-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	Preferred Pharmaceuticals Inc.	02158832-550b-4855-a5c5-6abbf13ed6f0	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352 ndc (package): 68788-4182-4 ndc (product): 68788-4182 ndc11 (package): 68788418204
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	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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-4182-4	68788418204	18 TABLET in 1 BOTTLE, PLASTIC (68788-4182-4)	18 tablet	2026-08-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)	Preferred Pharmaceuticals Inc.	2026-08-20	HUMAN PRESCRIPTION DRUG LABEL	1