PrednisoLONE

Product NDC: 0603-1567
11-digit product format: 006031567
Labeler code: 0603
Product ID: 0603-1567_5aad3237-1f8b-48f7-bac1-9d30c2cccbb3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisolone
Dosage form: SYRUP
Route: ORAL
Labeler: Par Pharmaceutical
Application: ANDA040775
Marketing category: ANDA
Marketing start: 2007-09-21
Marketing end: 2019-06-30
Substance: PREDNISOLONE
Active strength: 15 mg/5mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0603-1567		D	Discontinued by firm	2026-10-21
excluded package	package	0603-1567	0603-1567-56	D	Discontinued by firm	2026-10-21
excluded package	package	0603-1567	0603-1567-58	D	Discontinued by firm	2026-10-21

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 · 36 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	0603-1567-56	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0603-1567-58	`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	0603-1567-56	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0603-1567-58	`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	0603-1567-56	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0603-1567-58	`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	0603-1567-56	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0603-1567-58	`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	0603-1567-56	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0603-1567-58	`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	0603-1567-56	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-1567-58	`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	0603-1567-56	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-1567-58	`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	0603-1567-56	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-1567-58	`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	0603-1567-56	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-1567-58	`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 package	package	0603-1567-56	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-1567-58	`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 package	package	0603-1567-56	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-1567-58	`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 package	package	0603-1567-56	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-1567-58	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A040775-001	PREDNISOLONE	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA		2007-09-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A040775-001	AA

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 · 44 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
2026-10-15 13:18:30	2026-09	A040775-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2007-09-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040775-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2007-09-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040775-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2007-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040775-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2007-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040775-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2007-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040775-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2007-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040775-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	2007-09-21	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A040775-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040775-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040775-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040775-001	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-1567-56	ML - Milliliter	0603-1567	53898d87-2785-4426-a870-a5cabd6a10c0	1	2013-08-02
0603-1567-58	ML - Milliliter	0603-1567	5d147223-d6da-42a1-8e3a-23a7204160cb	1	2013-08-02

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
PrednisoLONE	PREDNISOLONE	Lannett Company, Inc.	86652e2d-664a-4388-a611-c2a9aa4a4bc8	2024-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040775 application number: ANDA040775

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9PHQ9Y1OLM	PREDNISOLONE	50-24-8	PREDNISOLONE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PrednisoLONE Syrup (PrednisoLONE Oral Solution USP) 15 mg/5 mL	Preferred Pharmaceuticals Inc	2018-07-23	HUMAN PRESCRIPTION DRUG LABEL	1