PREDNISONE

Product NDC: 61919-404
Requested package NDC: 61919-404-21
11-digit product format: 619190404
Labeler code: 61919
Product ID: 61919-404_9cac41a7-08ea-191c-e053-2a95a90af44d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREDNISONE
Dosage form: TABLET
Route: ORAL
Labeler: Direct Rx
Application: ANDA088832
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 10 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	61919-404	61919-404-21	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 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…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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	Approval date	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A088832-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088832-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088832-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088832-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088832-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088832-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088832-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088832-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088832-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088832-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088832-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088832-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088832-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088832-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088832-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088832-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088832-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088832-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088832-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088832-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088832-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088832-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088832-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088832-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088832-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088832-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088832-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088832-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088832-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088832-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088832-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088832-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088832-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088832-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088832-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088832-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088832-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088832-001	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
61919-404-21	2023-01-30	C162847	48780-1	f386c649-b427-0266-e053-dadaa90a7c1a	PREDNISONE
61919-404-30	2023-01-30	C162847	48780-1	f386c649-b427-0266-e053-dadaa90a7c1a	PREDNISONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-404-21	PREDNISONE	21 in 1 BOTTLE	TABLET	21		3
61919-404-30	PREDNISONE	30 in 1 BOTTLE	TABLET	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-404-21	EA - Each	61919-404	87e934cd-a5bd-46a3-9819-bbdd000ed7cb	1	2014-07-02
61919-404-30	EA - Each	61919-404	383d4292-a5a0-4e79-8106-7b7101a9cd72	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREDNISONE	ACTIVE INGREDIENT	VB0R961HZT	PREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]	1
PREDNISONE	ACTIVE MOIETY	VB0R961HZT	PREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-404	PREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]	3	Legacy NDC, 2 package rows	20200122_a10ce97b-3efc-443f-9c76-a2bfe2c57be3.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	Northwind Health Company, LLC	f76db82a-826e-92b0-e053-6294a90a8ec6	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088832 application number: ANDA088832
Prednisone	PREDNISONE	Golden State Medical Supply, Inc.	1e05e071-0407-0970-e063-6294a90a6c65	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088832 application number: ANDA088832
Prednisone	PREDNISONE	Mylan Pharmaceuticals Inc.	fec09050-5ac2-451b-a2b9-5a21b2def212	2024-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088832 application number: ANDA088832

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	a10ce97b-3efc-443f-9c76-a2bfe2c57be3	3
312617	predniSONE 5 MG Oral Tablet	PSN	a10ce97b-3efc-443f-9c76-a2bfe2c57be3	3
198145	prednisone 10 MG Oral Tablet	SCD	a10ce97b-3efc-443f-9c76-a2bfe2c57be3	3
312617	prednisone 5 MG Oral Tablet	SCD	a10ce97b-3efc-443f-9c76-a2bfe2c57be3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-404-21	61919040421	21 TABLET in 1 BOTTLE (61919-404-21)	21 tablet	2015-01-01	0000-00-00	No	No	Current