JAYTHARI Oral Suspension

Product NDC: 81806-213
Requested package NDC: 81806-213-13
11-digit product format: 818060213
Labeler code: 81806
Product ID: 81806-213_5b226f70-c857-820c-e063-6294a90a4441
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Deflazacort
Dosage form: SUSPENSION
Route: ORAL
Labeler: Doppel Farmaceutici S.r.l.
Application: ANDA220042
Marketing category: ANDA
Marketing start: 2025-11-20
Substance: DEFLAZACORT
Active strength: 22.75 mg/mL
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
A220042-001	DEFLAZACORT	DEFLAZACORT	22.75MG/ML	SUSPENSION / ORAL	AB		2025-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A220042-001	AB

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	A220042-001	DEFLAZACORT	22.75MG/ML	SUSPENSION / ORAL	AB	2025-10-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A220042-001	DEFLAZACORT	22.75MG/ML	SUSPENSION / ORAL	AB	2025-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A220042-001	DEFLAZACORT	22.75MG/ML	SUSPENSION / ORAL	AB	2025-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A220042-001	DEFLAZACORT	22.75MG/ML	SUSPENSION / ORAL	AB	2025-10-03	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220042-001	DEFLAZACORT	22.75MG/ML	SUSPENSION / ORAL	AB	2025-10-03	`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	A220042-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A220042-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A220042-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A220042-001	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220042-001	AB	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: JAYTHARI Oral Suspension
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEFLAZACORT	22.75 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KR5YZ6AE4B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1870964	Internal RxNorm lookup
2727381	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
43f3890e-0b1d-9bb5-e063-6294a90aa622	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
JAYTHARI Oral Suspension	DEFLAZACORT	Doppel Farmaceutici S.r.l.	43f3890e-0b1d-9bb5-e063-6294a90aa622	2026-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 220042 application number: ANDA220042 ndc (package): 81806-213-13 ndc (product): 81806-213 ndc11 (package): 81806021313
Deflazacort Oral Suspension	DEFLAZACORT	Doppel Farmaceutici S.r.l.	40a833a4-e029-a99e-e063-6394a90afd50	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 220042 application number: ANDA220042

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KR5YZ6AE4B	DEFLAZACORT	14484-47-0	DEFLAZACORT

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81806-213-13	81806021313	1 BOTTLE in 1 CARTON (81806-213-13) / 13 mL in 1 BOTTLE	1 bottle	2025-11-20	No	No	Current