PredniSONE

Product NDC: 66336-058
11-digit product format: 663360058
Labeler code: 66336
Product ID: 66336-058_5806e4cf-77b1-4d57-8ce8-ef11dc30144c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PredniSONE
Dosage form: TABLET
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: ANDA084122
Marketing category: ANDA
Marketing start: 2003-02-13
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 10 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66336-058		I	Inactivated by FDA	2026-08-17
excluded product	product	66336-058		I	Inactivated by FDA	2026-08-17
excluded package	package	66336-058	66336-058-15	I	Inactivated by FDA	2026-08-17
excluded package	package	66336-058	66336-058-90	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 2 · 88 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66336-058-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66336-058-15	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66336-058-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66336-058-15	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66336-058-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66336-058-15	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66336-058-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66336-058-15	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66336-058-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66336-058-15	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66336-058-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66336-058-15	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66336-058-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66336-058-15	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66336-058-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66336-058-15	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66336-058-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66336-058-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66336-058-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66336-058-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66336-058-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66336-058-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66336-058-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66336-058-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66336-058-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66336-058-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66336-058-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66336-058-15	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66336-058-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66336-058-15	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084122-001	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084122-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084122-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084122-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084122-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084122-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084122-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084122-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084122-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084122-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084122-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084122-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084122-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084122-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084122-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084122-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084122-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084122-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084122-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084122-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084122-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084122-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084122-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084122-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084122-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084122-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084122-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084122-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084122-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084122-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084122-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084122-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084122-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084122-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084122-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084122-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084122-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084122-001	AB	1	`cb3db0bc1861…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66336-058-15	2020-01-31	C162847	48780-1	9d75b9d0-882d-f424-e053-dadaa90a57ce	PredniSONE Tablets USP, 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg, PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL
66336-058-90	2019-11-27	C162847	48780-1	9855d018-e1b9-cd31-e053-dbdaa90ab51a	PredniSONE Tablets USP, 1 mg, 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66336-058-90	PredniSONE	90 in 1 BOTTLE, PLASTIC	TABLET	90		3
66336-058-15	PredniSONE	15 in 1 BOTTLE	TABLET	15		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66336-058	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	3	Legacy NDC, 1 package rows	20130409_ee0621e8-fecd-4b9e-9e1b-91a4abf22bdb.zip
66336-058	PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]	2	Legacy NDC, 1 package rows	20120929_e23a0f1e-e8ff-4be2-a74f-bc54cd44b3db.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PredniSONE	PREDNISONE	Northwind Health Company, LLC	dad4f191-8893-48e0-e053-2995a90ae864	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084122 application number: ANDA084122
PredniSONE	PREDNISONE	QPharma, Inc.	318fdf0d-c03a-4b48-a380-b7bb630363fb	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084122 application number: ANDA084122
PredniSONE	PREDNISONE	REMEDYREPACK INC.	94715919-70bd-46c9-95fc-e151adf39cf9	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084122 application number: ANDA084122
PredniSONE	PREDNISONE	Advanced Rx of Tennessee, LLC	2e630aa1-eccd-f5eb-e063-6294a90a4745	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084122 application number: ANDA084122

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
198144	predniSONE 1 MG Oral Tablet	PSN	ee0621e8-fecd-4b9e-9e1b-91a4abf22bdb	3
198145	predniSONE 10 MG Oral Tablet	PSN	ee0621e8-fecd-4b9e-9e1b-91a4abf22bdb	3
198144	prednisone 1 MG Oral Tablet	SCD	ee0621e8-fecd-4b9e-9e1b-91a4abf22bdb	3
198145	prednisone 10 MG Oral Tablet	SCD	ee0621e8-fecd-4b9e-9e1b-91a4abf22bdb	3
198145	predniSONE 10 MG Oral Tablet	PSN	e23a0f1e-e8ff-4be2-a74f-bc54cd44b3db	2
198145	prednisone 10 MG Oral Tablet	SCD	e23a0f1e-e8ff-4be2-a74f-bc54cd44b3db	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
66336-058-15	66336005815	15 in 1 BOTTLE	Historical
66336-058-90	66336005890	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PredniSONE Tablets USP, 1 mg, 10 mg	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-04-08	HUMAN PRESCRIPTION DRUG LABEL	3
PredniSONE	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-09-28	HUMAN PRESCRIPTION DRUG LABEL	2