Deflazacort

Product NDC
70095-040
11-digit product format
700950040
Labeler code
70095
Product ID
70095-040_4583474c-40e7-dd9d-e063-6294a90a902a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deflazacort
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA217741
Marketing category
ANDA
Marketing start
2025-03-19
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
70095-040-01Deflazacort100 in 1 BOTTLETABLET1002
70095-040-01Deflazacort1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70095-040DEFLAZACORT TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED]1Current NDC, 2 package rows20250321_fb5350d5-ead1-41f4-8b25-0da0bd7fcffe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870954deflazacort 18 MG Oral TabletPSNfb5350d5-ead1-41f4-8b25-0da0bd7fcffe2
153880deflazacort 30 MG Oral TabletPSNfb5350d5-ead1-41f4-8b25-0da0bd7fcffe2
1870958deflazacort 36 MG Oral TabletPSNfb5350d5-ead1-41f4-8b25-0da0bd7fcffe2
153098deflazacort 6 MG Oral TabletPSNfb5350d5-ead1-41f4-8b25-0da0bd7fcffe2
1870954deflazacort 18 MG Oral TabletSCDfb5350d5-ead1-41f4-8b25-0da0bd7fcffe2
153880deflazacort 30 MG Oral TabletSCDfb5350d5-ead1-41f4-8b25-0da0bd7fcffe2
1870958deflazacort 36 MG Oral TabletSCDfb5350d5-ead1-41f4-8b25-0da0bd7fcffe2
153098deflazacort 6 MG Oral TabletSCDfb5350d5-ead1-41f4-8b25-0da0bd7fcffe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70095-040-01700950040011 BOTTLE in 1 CARTON (70095-040-01) / 100 TABLET in 1 BOTTLE1 bottle2025-03-19NoNoCurrent