prednisone

Product NDC: 68788-8579
11-digit product format: 687888579
Labeler code: 68788
Product ID: 68788-8579_4a38efae-5e21-453b-9720-6ac049999f05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREDNISONE
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA209727
Marketing category: ANDA
Marketing start: 2024-02-02
Substance: PREDNISONE
Active strength: 5 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.

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 · 46 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
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209727-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209727-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209727-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209727-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209727-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209727-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209727-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209727-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209727-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209727-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209727-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209727-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209727-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209727-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209727-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209727-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209727-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209727-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209727-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209727-002	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209727-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209727-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209727-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209727-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209727-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209727-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209727-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209727-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209727-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209727-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209727-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209727-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209727-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209727-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209727-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209727-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209727-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209727-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209727-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209727-002	AB	1	`3a93d1ddd44b…`

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	5 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
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
fa75f5ce-8a74-4873-811f-7d9d9beec08f	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8579-3	prednisone	30 in 1 BOTTLE, PLASTIC	TABLET	30		2
68788-8579-8	prednisone	21 in 1 BOTTLE, PLASTIC	TABLET	21		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8579-3	EA - Each	68788-8579	926669a0-0ae2-4913-b88d-b36897cb1a37	1	2024-05-16
68788-8579-8	EA - Each	68788-8579	ceeca70d-321f-46d8-850f-4e68549cc550	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8579	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS INC.]	1	Current NDC, 2 package rows	20240306_fa75f5ce-8a74-4873-811f-7d9d9beec08f.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	fa75f5ce-8a74-4873-811f-7d9d9beec08f	2026-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209727 application number: ANDA209727 ndc (product): 68788-8579
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	930b5eea-3ec8-47df-a76d-1e0bc0b5c5b2	2026-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209727 application number: ANDA209727
prednisone	PREDNISONE	Bryant Ranch Prepack	07d5e455-ac3b-4890-9619-609dd0be9106	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209727 application number: ANDA209727
prednisone	PREDNISONE	Northwind Health Company, LLC	f2a15b5d-f540-2582-e053-2995a90a591a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209727 application number: ANDA209727
Prednisone	PREDNISONE	Direct_Rx	26194836-90c9-6909-e063-6294a90a6f98	2024-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209727 application number: ANDA209727
prednisone	PREDNISONE	A-S Medication Solutions	d40a97f6-60d1-4dbc-b4dc-650d82af5fae	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209727 application number: ANDA209727
prednisone	PREDNISONE	A-S Medication Solutions	17278e0a-cbff-4a95-96ee-f34f7466faa0	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209727 application number: ANDA209727

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
312617	predniSONE 5 MG Oral Tablet	PSN	fa75f5ce-8a74-4873-811f-7d9d9beec08f	2
312617	prednisone 5 MG Oral Tablet	SCD	fa75f5ce-8a74-4873-811f-7d9d9beec08f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8579-3	68788857903	30 TABLET in 1 BOTTLE, PLASTIC (68788-8579-3)	30 tablet	2024-02-02	No	No	Current
68788-8579-8	68788857908	21 TABLET in 1 BOTTLE, PLASTIC (68788-8579-8)	21 tablet	2024-02-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets USP Rx only	Preferred Pharmaceuticals Inc.	2026-08-19	HUMAN PRESCRIPTION DRUG LABEL	3