Deflazacort

Product NDC
59651-599
11-digit product format
596510599
Labeler code
59651
Product ID
59651-599_dc2886e0-4e19-4a7c-b7ae-5723d7b4b8c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deflazacort
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA217123
Marketing category
ANDA
Marketing start
2024-02-09
Substance
DEFLAZACORT
Active strength
6 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

Additional Listing Data#

Finished product
Yes
Brand name base
Deflazacort
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEFLAZACORT6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKR5YZ6AE4B
Rxcui153098, 153880, 1870954, 1870958

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
890642af-0787-4d04-9130-a3ba5909cd85Product name520260106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-599-01Deflazacort100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-599DEFLAZACORT TABLET [AUROBINDO PHARMA LIMITED]2Current NDC, 1 package rows20240627_77d7525d-89c9-4fde-a6a8-0a463fd6cfeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870954deflazacort 18 MG Oral TabletPSN77d7525d-89c9-4fde-a6a8-0a463fd6cfeb2
153880deflazacort 30 MG Oral TabletPSN77d7525d-89c9-4fde-a6a8-0a463fd6cfeb2
1870958deflazacort 36 MG Oral TabletPSN77d7525d-89c9-4fde-a6a8-0a463fd6cfeb2
153098deflazacort 6 MG Oral TabletPSN77d7525d-89c9-4fde-a6a8-0a463fd6cfeb2
1870954deflazacort 18 MG Oral TabletSCD77d7525d-89c9-4fde-a6a8-0a463fd6cfeb2
153880deflazacort 30 MG Oral TabletSCD77d7525d-89c9-4fde-a6a8-0a463fd6cfeb2
1870958deflazacort 36 MG Oral TabletSCD77d7525d-89c9-4fde-a6a8-0a463fd6cfeb2
153098deflazacort 6 MG Oral TabletSCD77d7525d-89c9-4fde-a6a8-0a463fd6cfeb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-599-0159651059901100 TABLET in 1 BOTTLE (59651-599-01) 100 tablet2024-02-09NoNoCurrent