Deltasone

Product NDC: 69668-220
Requested package NDC: 69668-220-20
11-digit product format: 696680220
Labeler code: 69668
Product ID: 69668-220_79b342b8-58b8-c73e-e053-2a91aa0a8e28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PredniSONE
Dosage form: TABLET
Route: ORAL
Labeler: Sonoma Pharmaceuticals, Inc.
Application: ANDA087342
Marketing category: ANDA
Marketing start: 2003-02-13
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69668-220	69668-220-20	I	Inactivated by FDA		2026-08-03

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`

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	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087342-001	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087342-001	PREDNISONE	20MG	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	A087342-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087342-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087342-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087342-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087342-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087342-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087342-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087342-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087342-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087342-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087342-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087342-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087342-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087342-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087342-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087342-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087342-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087342-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087342-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087342-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087342-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087342-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087342-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087342-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087342-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087342-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087342-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087342-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087342-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087342-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087342-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087342-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087342-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087342-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087342-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087342-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087342-001	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
69668-220-20	2023-01-30	C162847	48780-1	f386c649-c77f-0266-e053-dadaa90a7c1a	Deltasone Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69668-220-20	Deltasone	20 in 1 BOTTLE, PLASTIC	TABLET	20		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69668-220	DELTASONE (PREDNISONE) TABLET [SONOMA PHARMACEUTICALS, INC.]	13	Legacy NDC, 1 package rows	20181103_d0acd7fb-8401-424f-9acc-a74dcd9b14f6.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PredniSONE	PREDNISONE	Northwind Health Company, LLC	ca39fdfb-d110-6535-e053-2995a90a550a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087342 application number: ANDA087342

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
206997	Deltasone 20 MG Oral Tablet	PSN	d0acd7fb-8401-424f-9acc-a74dcd9b14f6	13
312615	predniSONE 20 MG Oral Tablet	PSN	d0acd7fb-8401-424f-9acc-a74dcd9b14f6	13
206997	prednisone 20 MG Oral Tablet [Deltasone]	SBD	d0acd7fb-8401-424f-9acc-a74dcd9b14f6	13
312615	prednisone 20 MG Oral Tablet	SCD	d0acd7fb-8401-424f-9acc-a74dcd9b14f6	13
206997	Deltasone 20 MG Oral Tablet	SY	d0acd7fb-8401-424f-9acc-a74dcd9b14f6	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69668-220-20	69668022020	20 TABLET in 1 BOTTLE, PLASTIC (69668-220-20)	20 tablet	2018-11-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Deltasone Tablets USP	Sonoma Pharmaceuticals, Inc. \| PD-Rx Pharmaceuticals, Inc.	2018-11-02	HUMAN PRESCRIPTION DRUG LABEL	13