Prednisone

Product NDC: 0591-5443
Requested package NDC: 0591-5443-77
11-digit product format: 005915443
Labeler code: 0591
Product ID: 0591-5443_6e6cf2e7-c839-4c9f-a58a-fea5023fb432
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA085161
Marketing category: ANDA
Marketing start: 1990-01-01
Substance: PREDNISONE
Active strength: 20 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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	0591-5443	0591-5443-77	UNFINISHED	Active or certified unfinished drug listing		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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`

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

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
A085161-001	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A085161-001	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 · 42 observed 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
2026-08-18 06:07:40	2026-07	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A085161-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085161-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085161-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085161-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085161-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085161-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085161-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085161-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085161-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085161-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085161-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085161-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085161-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085161-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085161-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085161-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085161-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085161-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085161-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085161-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085161-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085161-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085161-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085161-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085161-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085161-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085161-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085161-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085161-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085161-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085161-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085161-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085161-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085161-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085161-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085161-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085161-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085161-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085161-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085161-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

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 · 7 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198145	Internal RxNorm lookup
312615	Internal RxNorm lookup
312617	Internal RxNorm lookup
763179	Internal RxNorm lookup
763181	Internal RxNorm lookup
763183	Internal RxNorm lookup
763185	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
aa0b1582-6ef3-4697-9ea6-5391e6e57853	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
205c2cdd-a63b-cbc9-6bcb-6be6001edf81	Product name	2	20170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0591-5443-01	Prednisone	100 in 1 BOTTLE	TABLET	100	17
0591-5443-05	Prednisone	500 in 1 BOTTLE	TABLET	500	17
0591-5443-10	Prednisone	1000 in 1 BOTTLE	TABLET	1000	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-5443-01	EA - Each	0591-5443	510d2d03-dd69-4948-8b8d-5a4621996bac	1	2012-07-24
0591-5443-05	EA - Each	0591-5443	1b53e9ce-d00d-44ea-beaf-fc67a9f204d0	1	2012-07-24
0591-5443-10	EA - Each	0591-5443	9b01763c-5a62-4527-ae64-06c294d87565	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [WATSON LABORATORIES, INC.]	4
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [WATSON LABORATORIES, INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PREDNISONE TABLET [WATSON LABORATORIES, INC.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [WATSON LABORATORIES, INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PREDNISONE TABLET [WATSON LABORATORIES, INC.]	4
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	PREDNISONE TABLET [WATSON LABORATORIES, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [WATSON LABORATORIES, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [WATSON LABORATORIES, INC.]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PREDNISONE TABLET [WATSON LABORATORIES, INC.]	4
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [DIRECT RX]	1
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OR MCKESSON CORPORATION]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [DIRECT RX]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OR MCKESSON CORPORATION]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OR MCKESSON CORPORATION]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PREDNISONE TABLET [DIRECT RX]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [DIRECT RX]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OR MCKESSON CORPORATION]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PREDNISONE TABLET [DIRECT RX]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	PREDNISONE TABLET [DIRECT RX]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	PREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OR MCKESSON CORPORATION]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OR MCKESSON CORPORATION]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OR MCKESSON CORPORATION]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OR MCKESSON CORPORATION]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PREDNISONE TABLET [DIRECT RX]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OR MCKESSON CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-5443	PREDNISONE TABLET [ACTAVIS PHARMA, INC.]	17	Current NDC, Legacy NDC, 3 package rows	20250302_aa0b1582-6ef3-4697-9ea6-5391e6e57853.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	A-S Medication Solutions	aaaa3460-0239-4203-857f-0ada303c2108	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161
Prednisone	PREDNISONE	A-S Medication Solutions	de498de3-6ee6-4594-895e-cc69f050e34e	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161
Prednisone	PREDNISONE	A-S Medication Solutions	a6811c1f-3dad-46bb-b541-fddd2ff8e569	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161
Prednisone	PREDNISONE	Northwind Health Company, LLC	f6cb7924-4190-f130-e053-6294a90a21fe	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161
Prednisone	PREDNISONE	QPharma, Inc.	d898d53f-c7d2-4bdb-bd9e-5f200070d123	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161
Prednisone	PREDNISONE	Actavis Pharma, Inc.	aa0b1582-6ef3-4697-9ea6-5391e6e57853	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161 ndc (product): 0591-5443
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	7e541478-4a33-189f-e053-2a91aa0a6962	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161
Prednisone	PREDNISONE	Proficient Rx LP	016d65c3-fff2-4e0c-9025-e2083cfa6a1f	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161

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	de498de3-6ee6-4594-895e-cc69f050e34e	36
312615	predniSONE 20 MG Oral Tablet	PSN	de498de3-6ee6-4594-895e-cc69f050e34e	36
312617	predniSONE 5 MG Oral Tablet	PSN	de498de3-6ee6-4594-895e-cc69f050e34e	36
198145	prednisone 10 MG Oral Tablet	SCD	de498de3-6ee6-4594-895e-cc69f050e34e	36
312615	prednisone 20 MG Oral Tablet	SCD	de498de3-6ee6-4594-895e-cc69f050e34e	36
312617	prednisone 5 MG Oral Tablet	SCD	de498de3-6ee6-4594-895e-cc69f050e34e	36
763185	{21 (prednisone 10 MG Oral Tablet) } Pack	GPCK	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
763181	{21 (prednisone 5 MG Oral Tablet) } Pack	GPCK	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
763183	{48 (prednisone 10 MG Oral Tablet) } Pack	GPCK	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
763179	{48 (prednisone 5 MG Oral Tablet) } Pack	GPCK	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
198145	predniSONE 10 MG Oral Tablet	PSN	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
763183	predniSONE 10 MG Tablet 12 Day 48 Count Pack	PSN	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
763185	predniSONE 10 MG Tablet 6 Day 21 Count Pack	PSN	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
312615	predniSONE 20 MG Oral Tablet	PSN	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
312617	predniSONE 5 MG Oral Tablet	PSN	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
763179	predniSONE 5 MG Tablet 12 Day 48 Count Pack	PSN	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
763181	predniSONE 5 MG Tablet 21 Count Pack	PSN	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
198145	prednisone 10 MG Oral Tablet	SCD	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
312615	prednisone 20 MG Oral Tablet	SCD	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
312617	prednisone 5 MG Oral Tablet	SCD	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
763185	Prednisone 10 MG Oral Tablet 21 Count Pack	SY	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
763183	Prednisone 10 MG Oral Tablet 48 Count Pack	SY	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
763181	Prednisone 5 MG Oral Tablet 21 Count Pack	SY	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
763179	Prednisone 5 MG Oral Tablet 48 Count Pack	SY	aa0b1582-6ef3-4697-9ea6-5391e6e57853	17
312615	predniSONE 20 MG Oral Tablet	PSN	a6811c1f-3dad-46bb-b541-fddd2ff8e569	11
312615	prednisone 20 MG Oral Tablet	SCD	a6811c1f-3dad-46bb-b541-fddd2ff8e569	11
312615	predniSONE 20 MG Oral Tablet	PSN	d9b1652b-820a-4971-ab71-58bd55908b4d	9
312615	prednisone 20 MG Oral Tablet	SCD	d9b1652b-820a-4971-ab71-58bd55908b4d	9
312615	predniSONE 20 MG Oral Tablet	PSN	81695f4d-b975-691e-e053-2991aa0a5d63	8
312615	prednisone 20 MG Oral Tablet	SCD	81695f4d-b975-691e-e053-2991aa0a5d63	8
312615	predniSONE 20 MG Oral Tablet	PSN	d898d53f-c7d2-4bdb-bd9e-5f200070d123	7
312615	prednisone 20 MG Oral Tablet	SCD	d898d53f-c7d2-4bdb-bd9e-5f200070d123	7
312615	predniSONE 20 MG Oral Tablet	PSN	13a6f44a-c0b9-48b0-8577-bc1120381a33	6
312615	prednisone 20 MG Oral Tablet	SCD	13a6f44a-c0b9-48b0-8577-bc1120381a33	6
312615	predniSONE 20 MG Oral Tablet	PSN	f6cb7924-4190-f130-e053-6294a90a21fe	4
312615	predniSONE 20 MG Oral Tablet	PSN	016d65c3-fff2-4e0c-9025-e2083cfa6a1f	4
312615	predniSONE 20 MG Oral Tablet	PSN	7e541478-4a33-189f-e053-2a91aa0a6962	4
312615	prednisone 20 MG Oral Tablet	SCD	7e541478-4a33-189f-e053-2a91aa0a6962	4
312615	prednisone 20 MG Oral Tablet	SCD	f6cb7924-4190-f130-e053-6294a90a21fe	4
312615	prednisone 20 MG Oral Tablet	SCD	016d65c3-fff2-4e0c-9025-e2083cfa6a1f	4
198145	predniSONE 10 MG Oral Tablet	PSN	112a16d0-4ac6-164d-e054-00144ff88e88	1
312615	predniSONE 20 MG Oral Tablet	PSN	92ad0264-035e-b12a-e053-2a95a90a684e	1
312615	predniSONE 20 MG Oral Tablet	PSN	91ce3df8-9d2b-5479-e053-2a95a90aab84	1
312615	predniSONE 20 MG Oral Tablet	PSN	8f8cc292-4417-0a3b-e053-2a95a90ace3a	1
312615	predniSONE 20 MG Oral Tablet	PSN	8e6dceeb-132f-f12d-e053-2995a90a2241	1
312615	predniSONE 20 MG Oral Tablet	PSN	112a16d0-4ac6-164d-e054-00144ff88e88	1
198145	prednisone 10 MG Oral Tablet	SCD	112a16d0-4ac6-164d-e054-00144ff88e88	1
312615	prednisone 20 MG Oral Tablet	SCD	92ad0264-035e-b12a-e053-2a95a90a684e	1
312615	prednisone 20 MG Oral Tablet	SCD	91ce3df8-9d2b-5479-e053-2a95a90aab84	1
312615	prednisone 20 MG Oral Tablet	SCD	8f8cc292-4417-0a3b-e053-2a95a90ace3a	1
312615	prednisone 20 MG Oral Tablet	SCD	8e6dceeb-132f-f12d-e053-2995a90a2241	1
312615	prednisone 20 MG Oral Tablet	SCD	112a16d0-4ac6-164d-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
0591-5443-77	00591544377	36912 TABLET in 1 CONTAINER (0591-5443-77)	36912 tablet	30-JUN-24	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
predniSONE Tablets, USP Rx only	A-S Medication Solutions	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	33
predniSONE Tablets, USP Rx only	A-S Medication Solutions	2026-05-08	HUMAN PRESCRIPTION DRUG LABEL	36
predniSONE Tablets, USP Rx only	A-S Medication Solutions	2026-05-08	HUMAN PRESCRIPTION DRUG LABEL	11
predniSONE Tablets, USP Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
predniSONE Tablets, USP Rx only	QPharma, Inc. \| Actavis Pharma, Inc. \| Northwind Health Company, LLC	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	7
PredniSONE Tablets, USP Revised: October 2015 Rx Only	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2024-08-23	HUMAN PRESCRIPTION DRUG LABEL	11
PredniSONE Tablets, USP Revised: October 2015 Rx Only	REMEDYREPACK INC.	2024-08-09	HUMAN PRESCRIPTION DRUG LABEL	11
PredniSONE Tablets, USP Revised: October 2015 Rx Only	RedPharm Drug, Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	8
predniSONE Tablets, USP Rx only	Actavis Pharma, Inc.	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL	17
PredniSONE Tablets, USP Revised: October 2015 Rx Only	NuCare Pharmaceuticals,Inc.	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	4
PredniSONE Tablets, USP Revised: October 2015 Rx Only	REMEDYREPACK INC.	2024-02-28	HUMAN PRESCRIPTION DRUG LABEL	7
PredniSONE Tablets, USP Revised: October 2015 Rx Only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	6
PREDNISONE	Direct_Rx	2023-04-19	HUMAN PRESCRIPTION DRUG LABEL	9
PredniSONE Tablets, USP Revised: October 2015 Rx Only	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	4
PredniSONE Tablets, USP Revised: October 2015 Rx Only	NuCare Pharmaceuticals,Inc.	2022-01-14	HUMAN PRESCRIPTION DRUG LABEL	6
PredniSONE Tablets, USP Revised: October 2015 Rx Only	Preferred Pharmaceuticals, Inc.	2021-10-12	HUMAN PRESCRIPTION DRUG LABEL	2
PredniSONE Tablets, USP Revised: October 2015 Rx Only	REMEDYREPACK INC.	2021-02-15	HUMAN PRESCRIPTION DRUG LABEL	5
PredniSONE Tablets, USP Revised: October 2015 Rx Only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-04	HUMAN PRESCRIPTION DRUG LABEL	4
PredniSONE Tablets, USP Revised: October 2015 Rx Only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-04	HUMAN PRESCRIPTION DRUG LABEL	1
PredniSONE Tablets, USP Revised: October 2015 Rx Only	Bryant Ranch Prepack	2020-07-07	HUMAN PRESCRIPTION DRUG LABEL	5
PredniSONE Tablets, USP Revised: October 2015 Rx Only	Bryant Ranch Prepack	2020-07-07	HUMAN PRESCRIPTION DRUG LABEL	1
PredniSONE Tablets, USP Revised: October 2015 Rx Only	Bryant Ranch Prepack	2020-01-19	HUMAN PRESCRIPTION DRUG LABEL	5
PREDNISONE	Direct_Rx \| PREDNISONE	2019-09-16	HUMAN PRESCRIPTION DRUG LABEL	1
PredniSONE Tablets, USP Revised: October 2015 Rx Only	Bryant Ranch Prepack	2019-09-11	HUMAN PRESCRIPTION DRUG LABEL	1