Prednisone

Product NDC: 63187-085
11-digit product format: 631870085
Labeler code: 63187
Product ID: 63187-085_17eee13e-d667-4813-94f2-b0b8f9067c38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA083677
Marketing category: ANDA
Marketing start: 2009-08-03
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 20 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63187-085		D	Discontinued by firm	2026-08-17
excluded package	package	63187-085	63187-085-05	D	Discontinued by firm	2026-08-17
excluded package	package	63187-085	63187-085-06	D	Discontinued by firm	2026-08-17
excluded package	package	63187-085	63187-085-09	D	Discontinued by firm	2026-08-17
excluded package	package	63187-085	63187-085-10	D	Discontinued by firm	2026-08-17
excluded package	package	63187-085	63187-085-15	D	Discontinued by firm	2026-08-17
excluded package	package	63187-085	63187-085-20	D	Discontinued by firm	2026-08-17
excluded package	package	63187-085	63187-085-21	D	Discontinued by firm	2026-08-17
excluded package	package	63187-085	63187-085-24	D	Discontinued by firm	2026-08-17
excluded package	package	63187-085	63187-085-30	D	Discontinued by firm	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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-085-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-085-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-085-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-085-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-085-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-085-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-085-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-085-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-085-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-085-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-085-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-085-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-085-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-085-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-085-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-085-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-085-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-085-30	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A083677-001	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982
A083677-002	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982
A083677-003	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB		1985-12-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A083677-001	AB
A083677-002	AB
A083677-003	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 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083677-002	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083677-003	PREDNISONE	10MG	TABLET / ORAL	AB		1985-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083677-002	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083677-003	PREDNISONE	10MG	TABLET / ORAL	AB		1985-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-002	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-003	PREDNISONE	10MG	TABLET / ORAL	AB		1985-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 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	A083677-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083677-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083677-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083677-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083677-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083677-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083677-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083677-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083677-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083677-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083677-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083677-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083677-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083677-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083677-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083677-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083677-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083677-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083677-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083677-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083677-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083677-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083677-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083677-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083677-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083677-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083677-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083677-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083677-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083677-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083677-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083677-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083677-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083677-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083677-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083677-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083677-001	AB	1	`a67488948f0b…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [PROFICIENT RX LP]	5
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [PROFICIENT RX LP]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PREDNISONE TABLET [PROFICIENT RX LP]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [PROFICIENT RX LP]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PREDNISONE TABLET [PROFICIENT RX LP]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [PROFICIENT RX LP]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [PROFICIENT RX LP]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [PROFICIENT RX LP]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-085	PREDNISONE TABLET [PROFICIENT RX LP]	8	Legacy NDC	20191121_2b88faba-5302-47fe-a2f3-7d07c6871ad7.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Golden State Medical Supply, Inc.	1e05e071-0407-0970-e063-6294a90a6c65	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083677 application number: ANDA083677
Prednisone	PREDNISONE	Mylan Pharmaceuticals Inc.	fec09050-5ac2-451b-a2b9-5a21b2def212	2024-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083677 application number: ANDA083677

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VB0R961HZT	PREDNISONE	53-03-2	PREDNISONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-085-05	63187008505	5 TABLET in 1 BOTTLE (63187-085-05)	5 tablet	2018-11-01	0000-00-00	No	No	Current
63187-085-06	63187008506	6 TABLET in 1 BOTTLE (63187-085-06)	6 tablet	2018-11-01	0000-00-00	No	No	Current
63187-085-09	63187008509	9 TABLET in 1 BOTTLE (63187-085-09)	9 tablet	2018-11-01	0000-00-00	No	No	Current
63187-085-10	63187008510	10 TABLET in 1 BOTTLE (63187-085-10)	10 tablet	2018-11-01	0000-00-00	No	No	Current
63187-085-15	63187008515	15 TABLET in 1 BOTTLE (63187-085-15)	15 tablet	2018-11-01	0000-00-00	No	No	Current
63187-085-20	63187008520	20 TABLET in 1 BOTTLE (63187-085-20)	20 tablet	2018-11-01	0000-00-00	No	No	Current
63187-085-21	63187008521	21 TABLET in 1 BOTTLE (63187-085-21)	21 tablet	2018-11-01	0000-00-00	No	No	Current
63187-085-24	63187008524	24 TABLET in 1 BOTTLE (63187-085-24)	24 tablet	2018-11-01	0000-00-00	No	No	Current
63187-085-30	63187008530	30 TABLET in 1 BOTTLE (63187-085-30)	30 tablet	2018-11-01	0000-00-00	No	No	Current