Prednisone

Product NDC: 0378-0641
11-digit product format: 003780641
Labeler code: 0378
Product ID: 0378-0641_406aaa35-98b9-48ed-a10d-0aa29649588f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA088832
Marketing category: ANDA
Marketing start: 2019-04-03
Substance: PREDNISONE
Active strength: 10 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A088832-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088832-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088832-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088832-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088832-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088832-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088832-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088832-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088832-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088832-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088832-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088832-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088832-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088832-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088832-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088832-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088832-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088832-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088832-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088832-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088832-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088832-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088832-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088832-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088832-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088832-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088832-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088832-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088832-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088832-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088832-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088832-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088832-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088832-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088832-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088832-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088832-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088832-001	AB	1	`cb3db0bc1861…`

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	10 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
0378-0641-01	Prednisone	100 in 1 BOTTLE, PLASTIC	TABLET	100		9
0378-0641-10	Prednisone	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0641-01	EA - Each	0378-0641	ed75ff0c-b9bc-4a39-8a49-0b09bc5016e6	1	2019-05-02
0378-0641-10	EA - Each	0378-0641	0fb7c972-df59-4754-b9af-186aad431859	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-0641	PREDNISONE TABLET [MYLAN PHARMACEUTICALS INC.]	9	Current NDC, Legacy NDC, 2 package rows	20250221_fec09050-5ac2-451b-a2b9-5a21b2def212.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Northwind Health Company, LLC	f76db82a-826e-92b0-e053-6294a90a8ec6	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088832 application number: ANDA088832
Prednisone	PREDNISONE	Golden State Medical Supply, Inc.	1e05e071-0407-0970-e063-6294a90a6c65	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088832 application number: ANDA088832
Prednisone	PREDNISONE	Mylan Pharmaceuticals Inc.	fec09050-5ac2-451b-a2b9-5a21b2def212	2024-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088832 application number: ANDA088832 ndc (product): 0378-0641

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	fec09050-5ac2-451b-a2b9-5a21b2def212	9
312615	predniSONE 20 MG Oral Tablet	PSN	fec09050-5ac2-451b-a2b9-5a21b2def212	9
312617	predniSONE 5 MG Oral Tablet	PSN	fec09050-5ac2-451b-a2b9-5a21b2def212	9
198145	prednisone 10 MG Oral Tablet	SCD	fec09050-5ac2-451b-a2b9-5a21b2def212	9
312615	prednisone 20 MG Oral Tablet	SCD	fec09050-5ac2-451b-a2b9-5a21b2def212	9
312617	prednisone 5 MG Oral Tablet	SCD	fec09050-5ac2-451b-a2b9-5a21b2def212	9
198145	predniSONE 10 MG Oral Tablet	PSN	f76db82a-826e-92b0-e053-6294a90a8ec6	4
198145	prednisone 10 MG Oral Tablet	SCD	f76db82a-826e-92b0-e053-6294a90a8ec6	4
198145	predniSONE 10 MG Oral Tablet	PSN	1e05e071-0407-0970-e063-6294a90a6c65	2
312615	predniSONE 20 MG Oral Tablet	PSN	1e05e071-0407-0970-e063-6294a90a6c65	2
312617	predniSONE 5 MG Oral Tablet	PSN	1e05e071-0407-0970-e063-6294a90a6c65	2
198145	prednisone 10 MG Oral Tablet	SCD	1e05e071-0407-0970-e063-6294a90a6c65	2
312615	prednisone 20 MG Oral Tablet	SCD	1e05e071-0407-0970-e063-6294a90a6c65	2
312617	prednisone 5 MG Oral Tablet	SCD	1e05e071-0407-0970-e063-6294a90a6c65	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0641-01	00378064101	100 TABLET in 1 BOTTLE, PLASTIC (0378-0641-01)	100 tablet	2019-04-03	0000-00-00	No	No	Current
0378-0641-10	00378064110	1000 TABLET in 1 BOTTLE, PLASTIC (0378-0641-10)	1000 tablet	2019-04-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prednisone - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2026-09-15	HUMAN PRESCRIPTION DRUG LABEL	10
Prednisone - Northwind Health Company, LLC	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Prednisone Tablets.	Golden State Medical Supply, Inc.	2025-02-18	HUMAN PRESCRIPTION DRUG LABEL	2
Prednisone - REMEDYREPACK INC.	REMEDYREPACK INC.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	7