Prednisone

Product NDC: 0378-0640
11-digit product format: 003780640
Labeler code: 0378
Product ID: 0378-0640_f7cba7fb-7b9f-4464-a702-5c4f818aeb5f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA080292
Marketing category: ANDA
Marketing start: 2019-03-07
Substance: PREDNISONE
Active strength: 5 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.

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	RLD / RS	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`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	A080292-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080292-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080292-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080292-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080292-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080292-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080292-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080292-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080292-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080292-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080292-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080292-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080292-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080292-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080292-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080292-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080292-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080292-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080292-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080292-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080292-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080292-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080292-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080292-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080292-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080292-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080292-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080292-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080292-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080292-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080292-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080292-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080292-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080292-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080292-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080292-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080292-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080292-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

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 · 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
fec09050-5ac2-451b-a2b9-5a21b2def212	Available on FDA.report

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
0378-0640-01	Prednisone	100 in 1 BOTTLE, PLASTIC	TABLET	100		9
0378-0640-10	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
0378-0640-01	EA - Each	0378-0640	42662e2c-742f-4b38-97d8-f049ef39a809	1	2019-04-11
0378-0640-10	EA - Each	0378-0640	4a2ede23-deca-4cc3-bad5-5e3833cff6ca	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-0640	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Northwind Health Company, LLC	da7f948f-8039-5f0d-e053-2a95a90ad0f0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080292 application number: ANDA080292
Prednisone	PREDNISONE	QPharma, Inc.	c0e147a8-36a9-1e61-e053-2a95a90afd62	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080292 application number: ANDA080292
Prednisone	PREDNISONE	Golden State Medical Supply, Inc.	1e05e071-0407-0970-e063-6294a90a6c65	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080292 application number: ANDA080292
Prednisone	PREDNISONE	Bryant Ranch Prepack	91167f27-6f36-4b89-a530-be26209e4301	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080292 application number: ANDA080292
Prednisone	PREDNISONE	Mylan Pharmaceuticals Inc.	fec09050-5ac2-451b-a2b9-5a21b2def212	2024-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080292 application number: ANDA080292 ndc (product): 0378-0640

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	91167f27-6f36-4b89-a530-be26209e4301	103
312617	prednisone 5 MG Oral Tablet	SCD	91167f27-6f36-4b89-a530-be26209e4301	103
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
312617	predniSONE 5 MG Oral Tablet	PSN	c0e147a8-36a9-1e61-e053-2a95a90afd62	5
312617	prednisone 5 MG Oral Tablet	SCD	c0e147a8-36a9-1e61-e053-2a95a90afd62	5
312617	predniSONE 5 MG Oral Tablet	PSN	da7f948f-8039-5f0d-e053-2a95a90ad0f0	4
312617	prednisone 5 MG Oral Tablet	SCD	da7f948f-8039-5f0d-e053-2a95a90ad0f0	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	b934e4af-2292-cdda-e053-2995a90ae297	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	b934e4af-2292-cdda-e053-2995a90ae297	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
0378-0640-01	00378064001	100 TABLET in 1 BOTTLE, PLASTIC (0378-0640-01)	100 tablet	2019-03-07	0000-00-00	No	No	Current
0378-0640-10	00378064010	1000 TABLET in 1 BOTTLE, PLASTIC (0378-0640-10)	1000 tablet	2019-03-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prednisone - Northwind Health Company, LLC	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Prednisone - QPharma, Inc. \| Northwind Health Company, LLC	QPharma, Inc. \| Northwind Health Company, LLC	2025-12-01	HUMAN PRESCRIPTION DRUG LABEL	5
Prednisone Tablets.	Golden State Medical Supply, Inc.	2025-02-18	HUMAN PRESCRIPTION DRUG LABEL	2
Prednisone - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	103
prednisone 5mg tabs	RedPharm Drug, Inc. \| Redpharm Drug	2024-07-18	HUMAN PRESCRIPTION DRUG LABEL	2
Prednisone - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2024-06-23	HUMAN PRESCRIPTION DRUG LABEL	9
Prednisone - Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	1