Deflazacort Oral Suspension

Product NDC
81806-200
11-digit product format
818060200
Labeler code
81806
Product ID
81806-200_40a833b9-1c02-ffe2-e063-6294a90aac4e
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
2025-10-23
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
Deflazacort 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
890642af-0787-4d04-9130-a3ba5909cd85Product name520260106
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81806-200-73Deflazacort Oral Suspension13 mL in 1 BOTTLESUSPENSION131
81806-200-73Deflazacort Oral Suspension1 in 1 CARTONSUSPENSION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870964deflazacort 22.75 MG/mL Oral SuspensionPSN40a833a4-e029-a99e-e063-6394a90afd501
1870964deflazacort 22.75 MG/ML Oral SuspensionSCD40a833a4-e029-a99e-e063-6394a90afd501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81806-200-73818060200731 BOTTLE in 1 CARTON (81806-200-73) / 13 mL in 1 BOTTLE1 bottle2025-10-23NoNoCurrent