Prednisone

Product NDC: 51655-197
Requested package NDC: 51655-197-52
11-digit product format: 516550197
Labeler code: 51655
Product ID: 51655-197_48c4321c-73c8-2bb4-e063-6294a90a632d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA040581
Marketing category: ANDA
Marketing start: 2023-04-25
Substance: PREDNISONE
Active strength: 2.5 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 · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040581-001	PREDNISONE	PREDNISONE	2.5MG	TABLET / ORAL	AB		2004-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040581-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040581-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2004-12-21	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040581-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040581-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040581-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040581-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040581-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040581-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040581-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040581-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040581-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040581-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040581-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040581-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040581-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040581-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040581-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040581-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040581-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040581-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040581-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040581-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040581-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040581-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040581-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040581-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040581-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040581-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040581-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040581-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040581-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040581-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040581-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040581-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040581-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040581-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040581-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040581-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040581-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040581-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040581-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040581-001	AB	1	`f41ea6bd6efb…`

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	2.5 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
198146	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
faf6c0c5-e5f4-4de5-e053-6294a90abd1a	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
51655-197-52	Prednisone	30 in 1 BOTTLE, PLASTIC	TABLET	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-197	PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	3	Current NDC, 1 package rows	20241215_faf6c0c5-e5f4-4de5-e053-6294a90abd1a.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Par Health USA, LLC	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040581 application number: ANDA040581
Prednisone	PREDNISONE	Bryant Ranch Prepack	6c0376c4-87cf-40dc-b140-a6aac75b64f7	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040581 application number: ANDA040581
Prednisone	PREDNISONE	Northwind Health Company, LLC	faf6c0c5-e5f4-4de5-e053-6294a90abd1a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040581 application number: ANDA040581 ndc (package): 51655-197-52 ndc (product): 51655-197 ndc11 (package): 51655019752
Prednisone	PREDNISONE	Coupler LLC	2d99223a-853a-7640-e063-6394a90a260a	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040581 application number: ANDA040581

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
198146	predniSONE 2.5 MG Oral Tablet	PSN	faf6c0c5-e5f4-4de5-e053-6294a90abd1a	4
198146	prednisone 2.5 MG Oral Tablet	SCD	faf6c0c5-e5f4-4de5-e053-6294a90abd1a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-197-52	51655019752	30 TABLET in 1 BOTTLE, PLASTIC (51655-197-52)	30 tablet	2023-04-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets, USP 2.5 mg Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4