Deflazacort

Product NDC: 70710-2054
Requested package NDC: 70710-2054-3
11-digit product format: 707102054
Labeler code: 70710
Product ID: 70710-2054_02506db2-6183-481f-ae5f-aac325cf2c45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Deflazacort
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA219254
Marketing category: ANDA
Marketing start: 2025-06-12
Substance: DEFLAZACORT
Active strength: 36 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A219254-001	JAYTHARI	DEFLAZACORT	6MG	TABLET / ORAL	AB	2025-04-08
A219254-002	JAYTHARI	DEFLAZACORT	18MG	TABLET / ORAL	AB	2025-04-08
A219254-003	JAYTHARI	DEFLAZACORT	30MG	TABLET / ORAL	AB	2025-04-08
A219254-004	JAYTHARI	DEFLAZACORT	36MG	TABLET / ORAL	AB	2025-04-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A219254-001	AB
A219254-002	AB
A219254-003	AB
A219254-004	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
2026-02-19 14:30 UTC	2026-02	A219254-001	JAYTHARI	6MG	TABLET / ORAL	AB	2025-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219254-002	JAYTHARI	18MG	TABLET / ORAL	AB	2025-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219254-003	JAYTHARI	30MG	TABLET / ORAL	AB	2025-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219254-004	JAYTHARI	36MG	TABLET / ORAL	AB	2025-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-001	JAYTHARI	6MG	TABLET / ORAL	AB	2025-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-002	JAYTHARI	18MG	TABLET / ORAL	AB	2025-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-003	JAYTHARI	30MG	TABLET / ORAL	AB	2025-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-004	JAYTHARI	36MG	TABLET / ORAL	AB	2025-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219254-001	JAYTHARI	6MG	TABLET / ORAL	AB	2025-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219254-002	JAYTHARI	18MG	TABLET / ORAL	AB	2025-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219254-003	JAYTHARI	30MG	TABLET / ORAL	AB	2025-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219254-004	JAYTHARI	36MG	TABLET / ORAL	AB	2025-04-08	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-001	JAYTHARI	6MG	TABLET / ORAL	AB	2025-04-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-002	JAYTHARI	18MG	TABLET / ORAL	AB	2025-04-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-003	JAYTHARI	30MG	TABLET / ORAL	AB	2025-04-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-004	JAYTHARI	36MG	TABLET / ORAL	AB	2025-04-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A219254-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219254-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219254-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219254-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219254-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219254-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219254-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219254-004	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-004	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEFLAZACORT	36 mg/1

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
153098	Internal RxNorm lookup
153880	Internal RxNorm lookup
1870954	Internal RxNorm lookup
1870958	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
f99fde7c-91ac-4d67-bd76-2b18a1d31f7d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
890642af-0787-4d04-9130-a3ba5909cd85	Product name	5	20260106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70710-2054-3	Deflazacort	1 in 1 CARTON	TABLET	1		2
70710-2054-3	Deflazacort	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70710-2054-3	EA - Each	70710-2054	c4429b5b-82eb-4663-b198-46f9ad869d18	1	2025-11-13

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
Deflazacort	DEFLAZACORT	Zydus Pharmaceuticals (USA) Inc.	f99fde7c-91ac-4d67-bd76-2b18a1d31f7d	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219254 application number: ANDA219254 ndc (package): 70710-2054-3 ndc (product): 70710-2054 ndc11 (package): 70710205403
JAYTHARI	DEFLAZACORT	Zydus Pharmaceuticals (USA) Inc.	ced839ee-1131-45c6-9e38-cc81d85daf1c	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219254 application number: ANDA219254
Deflazacort	DEFLAZACORT	AvKARE	459b75a2-3242-3048-e063-6394a90ab882	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219254 application number: ANDA219254

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1870954	deflazacort 18 MG Oral Tablet	PSN	f99fde7c-91ac-4d67-bd76-2b18a1d31f7d	2
153880	deflazacort 30 MG Oral Tablet	PSN	f99fde7c-91ac-4d67-bd76-2b18a1d31f7d	2
1870958	deflazacort 36 MG Oral Tablet	PSN	f99fde7c-91ac-4d67-bd76-2b18a1d31f7d	2
153098	deflazacort 6 MG Oral Tablet	PSN	f99fde7c-91ac-4d67-bd76-2b18a1d31f7d	2
1870954	deflazacort 18 MG Oral Tablet	SCD	f99fde7c-91ac-4d67-bd76-2b18a1d31f7d	2
153880	deflazacort 30 MG Oral Tablet	SCD	f99fde7c-91ac-4d67-bd76-2b18a1d31f7d	2
1870958	deflazacort 36 MG Oral Tablet	SCD	f99fde7c-91ac-4d67-bd76-2b18a1d31f7d	2
153098	deflazacort 6 MG Oral Tablet	SCD	f99fde7c-91ac-4d67-bd76-2b18a1d31f7d	2
1870954	deflazacort 18 MG Oral Tablet	PSN	459b75a2-3242-3048-e063-6394a90ab882	1
153880	deflazacort 30 MG Oral Tablet	PSN	459b75a2-3242-3048-e063-6394a90ab882	1
1870958	deflazacort 36 MG Oral Tablet	PSN	459b75a2-3242-3048-e063-6394a90ab882	1
153098	deflazacort 6 MG Oral Tablet	PSN	459b75a2-3242-3048-e063-6394a90ab882	1
1870954	deflazacort 18 MG Oral Tablet	SCD	459b75a2-3242-3048-e063-6394a90ab882	1
153880	deflazacort 30 MG Oral Tablet	SCD	459b75a2-3242-3048-e063-6394a90ab882	1
1870958	deflazacort 36 MG Oral Tablet	SCD	459b75a2-3242-3048-e063-6394a90ab882	1
153098	deflazacort 6 MG Oral Tablet	SCD	459b75a2-3242-3048-e063-6394a90ab882	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70710-2054-3	70710205403	1 BOTTLE in 1 CARTON (70710-2054-3) / 30 TABLET in 1 BOTTLE	1 bottle	2025-06-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Deflazacort	Zydus Pharmaceuticals (USA) Inc. \| Zydus Lifesciences Global FZE \| Doppel Farmaceutici S.r.l.	2026-07-23	HUMAN PRESCRIPTION DRUG LABEL	3
Deflazacort	AvKARE	2025-12-10	HUMAN PRESCRIPTION DRUG LABEL	1