prednisone

Product NDC: 68788-8267
11-digit product format: 687888267
Labeler code: 68788
Product ID: 68788-8267_86e6dbae-6816-4f06-8dd1-f8d48462331a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA213385
Marketing category: ANDA
Marketing start: 2022-09-23
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 5 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-8267		D	Discontinued by firm	2026-08-17
excluded package	package	68788-8267	68788-8267-1	D	Discontinued by firm	2026-08-17
excluded package	package	68788-8267	68788-8267-2	D	Discontinued by firm	2026-08-17
excluded package	package	68788-8267	68788-8267-3	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	68788-8267-1
excluded package	package	68788-8267-3
excluded package	package	68788-8267-2

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213385-001	PREDNISONE	PREDNISONE	1MG	TABLET / ORAL	AB		2020-06-16
A213385-002	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB		2020-06-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213385-001	AB
A213385-002	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 · 76 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
2026-08-18 06:07:40	2026-07	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A213385-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213385-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213385-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213385-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213385-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213385-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213385-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213385-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213385-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213385-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213385-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213385-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213385-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213385-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213385-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213385-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213385-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213385-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213385-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213385-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213385-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213385-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213385-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213385-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213385-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213385-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213385-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213385-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213385-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213385-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213385-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213385-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213385-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213385-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213385-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213385-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213385-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213385-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213385-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213385-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8267-2	EA - Each	68788-8267	2b19985d-978d-4754-87de-605b491b664a	1	2022-11-07
68788-8267-3	EA - Each	68788-8267	12772b2d-42ae-4b52-b7a7-67deaa611a9a	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8267	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS INC.]	3	Legacy NDC	20240802_86e6dbae-6816-4f06-8dd1-f8d48462331a.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	Amneal Pharmaceuticals NY LLC	0740ef68-7641-432e-bd46-4710687fc9d7	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385
prednisone	PREDNISONE	Northwind Health Company, LLC	e08ba8c5-5e26-6120-e053-2995a90a1364	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385
prednisone	PREDNISONE	A-S Medication Solutions	80705a8a-f007-4a18-82a6-a73733d57ea2	2025-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385
prednisone	PREDNISONE	A-S Medication Solutions	43a4b2eb-f2cd-410f-9719-577fdc4ad5de	2025-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385
prednisone	PREDNISONE	A-S Medication Solutions	6f326242-786c-44b5-9317-f5fb0485d8e2	2025-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385
prednisone	PREDNISONE	NCS HealthCare of KY, LLC dba Vangard Labs	bc37cc2e-2f6a-4131-bb6a-63b6e576df21	2022-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385

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	Marketing end	Sample	Exclude flag	Status
68788-8267-2	68788826702	21 TABLET in 1 BOTTLE, PLASTIC (68788-8267-2)	21 tablet	2022-09-23	0000-00-00	No	No	Current
68788-8267-3	68788826703	30 TABLET in 1 BOTTLE, PLASTIC (68788-8267-3)	30 tablet	2022-09-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP (1 mg and 5 mg) Rx only	Preferred Pharmaceuticals Inc.	2024-07-31	HUMAN PRESCRIPTION DRUG LABEL	3