Prednisone

Product NDC: 10544-509
11-digit product format: 105440509
Labeler code: 10544
Product ID: 10544-509_e14b112a-d01a-4d96-ae6a-7c6466245809
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA083677
Marketing category: ANDA
Marketing start: 2010-03-17
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 20 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10544-509		I	Inactivated by FDA	2026-08-17
excluded package	package	10544-509	10544-509-07	I	Inactivated by FDA	2026-08-17
excluded package	package	10544-509	10544-509-10	I	Inactivated by FDA	2026-08-17
excluded package	package	10544-509	10544-509-12	I	Inactivated by FDA	2026-08-17
excluded package	package	10544-509	10544-509-15	I	Inactivated by FDA	2026-08-17
excluded package	package	10544-509	10544-509-20	I	Inactivated by FDA	2026-08-17
excluded package	package	10544-509	10544-509-30	I	Inactivated by FDA	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 3 · 154 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	10544-509-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-509-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-509-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-509-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-509-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-509-30	`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	10544-509-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-509-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-509-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-509-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-509-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-509-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-509-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-509-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-509-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-509-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-509-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-509-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-509-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-509-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-509-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-509-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-509-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-509-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-509-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-509-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-509-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-509-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-509-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-509-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-509-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-509-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-509-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-509-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-509-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-509-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-509-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-509-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-509-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-509-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-509-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-509-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-509-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-509-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-509-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-509-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-509-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-509-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-509-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-509-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-509-07	`0efc9e666f02…`	`f202fb6c5f17…`

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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
10544-509-07	Prednisone Tablets, USP Rev. 11/10
10544-509-10	Prednisone Tablets, USP Rev. 11/10
10544-509-12	Prednisone Tablets, USP Rev. 11/10
10544-509-15	Prednisone Tablets, USP Rev. 11/10
10544-509-20	Prednisone Tablets, USP Rev. 11/10
10544-509-30	Prednisone Tablets, USP Rev. 11/10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10544-509-07	Prednisone	7 in 1 BOTTLE	TABLET	7	1
10544-509-10	Prednisone	10 in 1 BOTTLE	TABLET	10	1
10544-509-12	Prednisone	12 in 1 BOTTLE	TABLET	12	1
10544-509-15	Prednisone	15 in 1 BOTTLE	TABLET	15	1
10544-509-20	Prednisone	20 in 1 BOTTLE	TABLET	20	1
10544-509-30	Prednisone	30 in 1 BOTTLE	TABLET	30	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-509-07	EA - Each	10544-509	95f577cf-db5d-4f33-b467-3fbc3caf935d	1	2015-10-02
10544-509-10	EA - Each	10544-509	29ecb4aa-45f1-4d69-a22d-1475aee472f2	1	2015-10-02
10544-509-12	EA - Each	10544-509	1b35cbf8-70d9-473b-aca6-5a111d12d94e	1	2015-10-02
10544-509-15	EA - Each	10544-509	98f4d965-a99c-4b45-8777-2ff4267a821d	1	2015-10-02
10544-509-20	EA - Each	10544-509	5ff776ee-533a-4eee-8358-8ea0503f20bc	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-509	PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 6 package rows	20130524_f25a6e4d-7966-4ebd-94e9-7fe9cadb897b.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198145	predniSONE 10 MG Oral Tablet	PSN	f25a6e4d-7966-4ebd-94e9-7fe9cadb897b	1
312615	predniSONE 20 MG Oral Tablet	PSN	f25a6e4d-7966-4ebd-94e9-7fe9cadb897b	1
198145	prednisone 10 MG Oral Tablet	SCD	f25a6e4d-7966-4ebd-94e9-7fe9cadb897b	1
312615	prednisone 20 MG Oral Tablet	SCD	f25a6e4d-7966-4ebd-94e9-7fe9cadb897b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-509-07	10544050907	7 in 1 BOTTLE	Historical
10544-509-10	10544050910	10 in 1 BOTTLE	Historical
10544-509-12	10544050912	12 in 1 BOTTLE	Historical
10544-509-15	10544050915	15 in 1 BOTTLE	Historical
10544-509-20	10544050920	20 in 1 BOTTLE	Historical
10544-509-30	10544050930	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prednisone Tablets, USP Rev. 11/10	Blenheim Pharmacal, Inc.	2013-05-23	HUMAN PRESCRIPTION DRUG LABEL	1