JAYTHARI Oral Suspension

Product NDC
70710-2131
11-digit product format
707102131
Labeler code
70710
Product ID
70710-2131_726f1539-369c-4fc4-a1fe-059457d26c49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deflazacort
Dosage form
SUSPENSION
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
JAYTHARI Oral Suspension
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEFLAZACORT22.75 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKR5YZ6AE4B
Rxcui1870964, 2727381

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
890642af-0787-4d04-9130-a3ba5909cd85Product name520260106
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-2131-3JAYTHARI Oral Suspension1 in 1 CARTONSUSPENSION11
70710-2131-3JAYTHARI Oral Suspension13 mL in 1 BOTTLESUSPENSION131

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870964deflazacort 22.75 MG/mL Oral SuspensionPSNabf1dba1-cfd8-4a05-aa2b-ffacfbeb9fa91
2727381JAYTHARI 22.75 MG/mL Oral SuspensionPSNabf1dba1-cfd8-4a05-aa2b-ffacfbeb9fa91
2727381deflazacort 22.75 MG/ML Oral Suspension [Jaythari]SBDabf1dba1-cfd8-4a05-aa2b-ffacfbeb9fa91
1870964deflazacort 22.75 MG/ML Oral SuspensionSCDabf1dba1-cfd8-4a05-aa2b-ffacfbeb9fa91
2727381Jaythari 22.75 MG/ML Oral SuspensionSYabf1dba1-cfd8-4a05-aa2b-ffacfbeb9fa91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-2131-3707102131031 BOTTLE in 1 CARTON (70710-2131-3) / 13 mL in 1 BOTTLE1 bottle2025-11-20NoNoCurrent