Deflazacort

Product NDC
0832-0814
11-digit product format
008320814
Labeler code
0832
Product ID
0832-0814_373dd14d-05b2-4408-e063-6394a90abf95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deflazacort
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA216720
Marketing category
ANDA
Marketing start
2024-11-05
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
0832-0814-11Deflazacort100 in 1 BOTTLETABLET1006
0832-0814-11Deflazacort1 in 1 CARTONTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0814-11EA - Each0832-08149a29a2b2-4559-420f-b53c-d927c28861de12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-0814DEFLAZACORT TABLET [UPSHER-SMITH LABORATORIES, LLC]4Current NDC, 2 package rows20250119_40818600-3ff0-4c9c-8e31-2001425a7dc9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870954deflazacort 18 MG Oral TabletPSN40818600-3ff0-4c9c-8e31-2001425a7dc96
153880deflazacort 30 MG Oral TabletPSN40818600-3ff0-4c9c-8e31-2001425a7dc96
1870958deflazacort 36 MG Oral TabletPSN40818600-3ff0-4c9c-8e31-2001425a7dc96
153098deflazacort 6 MG Oral TabletPSN40818600-3ff0-4c9c-8e31-2001425a7dc96
1870954deflazacort 18 MG Oral TabletSCD40818600-3ff0-4c9c-8e31-2001425a7dc96
153880deflazacort 30 MG Oral TabletSCD40818600-3ff0-4c9c-8e31-2001425a7dc96
1870958deflazacort 36 MG Oral TabletSCD40818600-3ff0-4c9c-8e31-2001425a7dc96
153098deflazacort 6 MG Oral TabletSCD40818600-3ff0-4c9c-8e31-2001425a7dc96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0832-0814-11008320814111 BOTTLE in 1 CARTON (0832-0814-11) / 100 TABLET in 1 BOTTLE1 bottle2025-01-17NoNoCurrent