Prednisone

Product NDC: 55154-2147
Requested package NDC: 55154-2147-0
11-digit product format: 551542147
Labeler code: 55154
Product ID: 55154-2147_90b391d7-e8eb-4bde-b018-fb1878e7772b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA040392
Marketing category: ANDA
Marketing start: 2025-07-09
Marketing end: 2027-03-31
Substance: PREDNISONE
Active strength: 20 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
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
A040392-001	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB		2003-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040392-001	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	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`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	A040392-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040392-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040392-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040392-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040392-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040392-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040392-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040392-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040392-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040392-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040392-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040392-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040392-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040392-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040392-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040392-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040392-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040392-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040392-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040392-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040392-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040392-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040392-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040392-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040392-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040392-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040392-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040392-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040392-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040392-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040392-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040392-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040392-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040392-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040392-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040392-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040392-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040392-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040392-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040392-001	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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISONE	20 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
199ed6a6-d9d9-49de-b383-5933a026591b	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
55154-2147-0	Prednisone	1 in 1 BLISTER PACK	TABLET	1		3
55154-2147-0	Prednisone	10 in 1 BAG	TABLET	10		3

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	Par Health USA, LLC	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040392 application number: ANDA040392
Prednisone	PREDNISONE	Cardinal Health 107, LLC	199ed6a6-d9d9-49de-b383-5933a026591b	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040392 application number: ANDA040392 ndc (package): 55154-2147-0 ndc (product): 55154-2147 ndc11 (package): 55154214700
Prednisone	PREDNISONE	American Health Packaging	a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040392 application number: ANDA040392

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
312615	predniSONE 20 MG Oral Tablet	PSN	199ed6a6-d9d9-49de-b383-5933a026591b	3
312617	predniSONE 5 MG Oral Tablet	PSN	199ed6a6-d9d9-49de-b383-5933a026591b	3
312615	prednisone 20 MG Oral Tablet	SCD	199ed6a6-d9d9-49de-b383-5933a026591b	3
312617	prednisone 5 MG Oral Tablet	SCD	199ed6a6-d9d9-49de-b383-5933a026591b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-2147-0	55154214700	10 BLISTER PACK in 1 BAG (55154-2147-0) / 1 TABLET in 1 BLISTER PACK	10 blister pack	2025-07-09	2027-03-31	No	No	Historical