Prednisone

Product NDC: 52959-127
11-digit product format: 529590127
Labeler code: 52959
Product ID: 52959-127_0fbab6d8-b9d9-4e8a-8023-3df614071406
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA040392
Marketing category: ANDA
Marketing start: 2003-02-12
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: 2018-12-31
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 · 13 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-127		I	Inactivated by FDA	2026-08-17
excluded package	package	52959-127	52959-127-07	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-127	52959-127-10	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-127	52959-127-11	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-127	52959-127-12	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-127	52959-127-15	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-127	52959-127-18	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-127	52959-127-20	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-127	52959-127-21	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-127	52959-127-25	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-127	52959-127-30	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-127	52959-127-37	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-127	52959-127-42	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 5 · 286 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	52959-127-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-127-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-127-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-127-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-127-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-127-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-127-37	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-127-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-127-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-127-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-127-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-127-20	`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	52959-127-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-127-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-127-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-127-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-127-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-127-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-127-37	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-127-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-127-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-127-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-127-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-127-20	`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	52959-127-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-127-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-127-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-127-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-127-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-127-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-127-37	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-127-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-127-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-127-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-127-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-127-20	`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	52959-127-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-127-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-127-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-127-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-127-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-127-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-127-37	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-127-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-127-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-127-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-127-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-127-20	`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	52959-127-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-127-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-127-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-127-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-127-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-127-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-127-37	`cfe11265f3b6…`	`090c488252e2…`

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
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 · 42 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
2026-08-18 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…`
2022-09-29 23:25 UTC	2022-09	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`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	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…`
2022-09-29 23:25 UTC	2022-09	A040392-001	AB	1	`e64feba35796…`

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
52959-127-07	PredniSONE TABLETS, USP 20 mg
52959-127-10	PredniSONE TABLETS, USP 20 mg
52959-127-11	PredniSONE TABLETS, USP 20 mg
52959-127-12	PredniSONE TABLETS, USP 20 mg
52959-127-15	PredniSONE TABLETS, USP 20 mg
52959-127-18	PredniSONE TABLETS, USP 20 mg
52959-127-20	PredniSONE TABLETS, USP 20 mg
52959-127-21	PredniSONE TABLETS, USP 20 mg
52959-127-25	PredniSONE TABLETS, USP 20 mg
52959-127-30	PredniSONE TABLETS, USP 20 mg
52959-127-37	PredniSONE TABLETS, USP 20 mg
52959-127-42	PredniSONE TABLETS, USP 20 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-127-07	Prednisone	7 in 1 BOTTLE, PLASTIC	TABLET	7	2
52959-127-10	Prednisone	10 in 1 BOTTLE, PLASTIC	TABLET	10	2
52959-127-11	Prednisone	11 in 1 BOTTLE, PLASTIC	TABLET	11	2
52959-127-12	Prednisone	12 in 1 BOTTLE, PLASTIC	TABLET	12	2
52959-127-15	Prednisone	15 in 1 BOTTLE, PLASTIC	TABLET	15	2
52959-127-18	Prednisone	18 in 1 BOTTLE, PLASTIC	TABLET	18	2
52959-127-20	Prednisone	20 in 1 BOTTLE, PLASTIC	TABLET	20	2
52959-127-21	Prednisone	21 in 1 BOTTLE, PLASTIC	TABLET	21	2
52959-127-25	Prednisone	25 in 1 BOTTLE, PLASTIC	TABLET	25	2
52959-127-30	Prednisone	30 in 1 BOTTLE, PLASTIC	TABLET	30	2
52959-127-37	Prednisone	37 in 1 BOTTLE, PLASTIC	TABLET	37	2
52959-127-42	Prednisone	42 in 1 BOTTLE, PLASTIC	TABLET	42	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-127-07	EA - Each	52959-127	aca26bbc-86d7-4995-9691-70caf56d2729	1	2013-02-13
52959-127-10	EA - Each	52959-127	c1690cb4-64ee-4ab1-8a46-1f12869cb360	1	2013-02-13
52959-127-12	EA - Each	52959-127	44909feb-cf4f-4497-92f4-ccc241f7b0a7	1	2013-02-13
52959-127-15	EA - Each	52959-127	ec748118-0241-4e85-82a3-82152d7a99a1	1	2013-02-13
52959-127-18	EA - Each	52959-127	d5398feb-b212-4eb6-9af7-5fce0fe451df	1	2013-02-13
52959-127-20	EA - Each	52959-127	805bc277-5455-4f1a-8444-7f21803b47bc	1	2013-02-13
52959-127-21	EA - Each	52959-127	c6e9c332-3295-44f4-93c4-982dc2502e77	1	2013-02-13
52959-127-25	EA - Each	52959-127	55dd82e0-559c-40e7-b8f8-edb44355e80b	1	2013-02-13
52959-127-30	EA - Each	52959-127	a9060540-80a4-4514-a78d-c193dad27e9b	1	2013-02-13
52959-127-37	EA - Each	52959-127	2d185549-01dc-4b54-8bef-6ced8af56e4d	1	2013-02-13
52959-127-42	EA - Each	52959-127	497eb4f9-ecb4-4ac4-a17b-5a6f9849ee7f	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	2
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-127	PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 12 package rows	20120830_dfb55c19-be0d-4c9f-8169-c63749da26c2.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 · 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
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	dfb55c19-be0d-4c9f-8169-c63749da26c2	2
312615	prednisone 20 MG Oral Tablet	SCD	dfb55c19-be0d-4c9f-8169-c63749da26c2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-127-07	52959012707	7 in 1 BOTTLE, PLASTIC	Historical
52959-127-10	52959012710	10 in 1 BOTTLE, PLASTIC	Historical
52959-127-11	52959012711	11 in 1 BOTTLE, PLASTIC	Historical
52959-127-12	52959012712	12 in 1 BOTTLE, PLASTIC	Historical
52959-127-15	52959012715	15 in 1 BOTTLE, PLASTIC	Historical
52959-127-18	52959012718	18 in 1 BOTTLE, PLASTIC	Historical
52959-127-20	52959012720	20 in 1 BOTTLE, PLASTIC	Historical
52959-127-21	52959012721	21 in 1 BOTTLE, PLASTIC	Historical
52959-127-25	52959012725	25 in 1 BOTTLE, PLASTIC	Historical
52959-127-30	52959012730	30 in 1 BOTTLE, PLASTIC	Historical
52959-127-37	52959012737	37 in 1 BOTTLE, PLASTIC	Historical
52959-127-42	52959012742	42 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE TABLETS, USP 20 mg	H.J. Harkins Company, Inc. \| Sharp Corporation \| Vintage Pharmaceuticals-Charlotte \| Vintage Pharmaceuticals-Huntsville	2012-08-29	HUMAN PRESCRIPTION DRUG LABEL	2