deflazacort

Generic: deflazacort

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name deflazacort
Generic Name deflazacort
Labeler upsher-smith laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

deflazacort 18 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-0815
Product ID 0832-0815_373dd14d-05b2-4408-e063-6394a90abf95
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216720
Listing Expiration 2026-12-31
Marketing Start 2024-11-05

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08320815
Hyphenated Format 0832-0815

Supplemental Identifiers

RxCUI
153098 153880 1870954 1870958
UNII
KR5YZ6AE4B
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name deflazacort (source: ndc)
Generic Name deflazacort (source: ndc)
Application Number ANDA216720 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 18 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0832-0815-30) / 30 TABLET in 1 BOTTLE
source: ndc

Packages (1)

0832-0815-30 1 BOTTLE in 1 CARTON (0832-0815-30) / 30 TABLET in 1 BOTTLE

Ingredients (1)

deflazacort (18 mg/1)

Linked Drug Pages (1)

Deflazacort ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "373dd14d-05b2-4408-e063-6394a90abf95", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["KR5YZ6AE4B"], "rxcui": ["153098", "153880", "1870954", "1870958"], "spl_set_id": ["40818600-3ff0-4c9c-8e31-2001425a7dc9"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0832-0815-30)  / 30 TABLET in 1 BOTTLE", "package_ndc": "0832-0815-30", "marketing_start_date": "20250117"}], "brand_name": "Deflazacort", "product_id": "0832-0815_373dd14d-05b2-4408-e063-6394a90abf95", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0832-0815", "generic_name": "Deflazacort", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Deflazacort", "active_ingredients": [{"name": "DEFLAZACORT", "strength": "18 mg/1"}], "application_number": "ANDA216720", "marketing_category": "ANDA", "marketing_start_date": "20241105", "listing_expiration_date": "20261231"}