Prednisolone

Product NDC: 63187-466
11-digit product format: 631870466
Labeler code: 63187
Product ID: 63187-466_387169e5-fdc7-4bd8-94f5-ce71571dd90e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisolone
Dosage form: SOLUTION
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA040401
Marketing category: ANDA
Marketing start: 2003-02-27
Marketing end: 0000-00-00
Substance: PREDNISOLONE
Active strength: 15 mg/5mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63187-466		D	Discontinued by firm		2026-08-07
excluded package	package	63187-466	63187-466-64	D	Discontinued by firm		2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040401-001	PREDNISOLONE	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL			2003-02-27

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040401-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL			2003-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040401-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL			2003-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040401-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL			2003-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA		2003-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA		2003-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA		2003-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA		2003-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA		2003-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA		2003-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040401-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040401-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040401-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040401-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040401-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040401-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040401-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040401-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040401-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040401-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040401-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040401-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040401-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040401-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040401-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040401-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040401-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040401-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040401-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040401-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040401-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040401-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040401-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040401-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040401-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040401-001	AA	1	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREDNISOLONE	ACTIVE INGREDIENT	9PHQ9Y1OLM	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	1
PREDNISOLONE	ACTIVE MOIETY	9PHQ9Y1OLM	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	1
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-466	PREDNISOLONE SOLUTION [PROFICIENT RX LP]	3	Legacy NDC	20200219_246703b1-a792-4653-a391-02d3c6212cb7.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-466-64	63187046664	1 BOTTLE in 1 CARTON (63187-466-64) > 240 mL in 1 BOTTLE	1 bottle	2019-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREDNISOLONE ORAL SOLUTION USP 15 mg per 5 mL	Proficient Rx LP	2020-02-01	HUMAN PRESCRIPTION DRUG LABEL	3