Prednisolone

Product NDC: 52817-860
Requested package NDC: 52817-860-08
11-digit product format: 528170860
Labeler code: 52817
Product ID: 52817-860_5a84db26-98d0-fe51-e063-6294a90a63ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisolone oral
Dosage form: SOLUTION
Route: ORAL
Labeler: TRUPHARMA, LLC
Application: ANDA219509
Marketing category: ANDA
Marketing start: 2026-08-04
Substance: PREDNISOLONE
Active strength: 15 mg/5mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A219509-001	PREDNISOLONE	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA		2025-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219509-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A219509-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2025-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219509-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2025-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219509-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2025-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219509-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2025-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219509-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2025-06-23	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219509-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA	2025-06-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A219509-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219509-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219509-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219509-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219509-001	AA	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219509-001	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Prednisolone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISOLONE	15 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9PHQ9Y1OLM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283077	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4f83514d-5342-4748-a0d3-b0306ca303c8	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisolone	PREDNISOLONE ORAL	TRUPHARMA, LLC	4f83514d-5342-4748-a0d3-b0306ca303c8	2026-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219509 application number: ANDA219509 ndc (package): 52817-860-08 ndc (product): 52817-860 ndc11 (package): 52817086008
Prednisolone	PREDNISOLONE ORAL	Tulex Pharmaceuticals Inc	757b41c4-a0fe-4a09-8816-a4cdb7558f41	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219509 application number: ANDA219509

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	Sample	Exclude flag	Status
52817-860-08	52817086008	240 mL in 1 BOTTLE (52817-860-08)	240 ml	2026-08-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREDNISOLONE ORAL SOLUTION, USP 15 mg per 5 mL Rx only	TRUPHARMA, LLC \| Tulex Pharmaceuticals Inc	2026-09-02	HUMAN PRESCRIPTION DRUG LABEL	1