dexamethasone

Generic: dexamethasone

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexamethasone
Generic Name dexamethasone
Labeler viona pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexamethasone 1 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-166
Product ID 72578-166_57d9469e-8d0d-4a58-a56c-3c266fe36b74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216284
Listing Expiration 2026-12-31
Marketing Start 2024-05-13

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 72578166
Hyphenated Format 72578-166

Supplemental Identifiers

RxCUI
197579
UNII
7S5I7G3JQL
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 dexamethasone (source: ndc)
Generic Name dexamethasone (source: ndc)
Application Number ANDA216284 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72578-166-01)
source: ndc

Packages (1)

72578-166-01 100 TABLET in 1 BOTTLE (72578-166-01)

Ingredients (1)

dexamethasone (1 mg/1)

Linked Drug Pages (1)

Dexamethasone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "57d9469e-8d0d-4a58-a56c-3c266fe36b74", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL"], "rxcui": ["197579"], "spl_set_id": ["360d3af0-8f69-4e82-ab5f-1f70cc2025d4"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72578-166-01)", "package_ndc": "72578-166-01", "marketing_start_date": "20240513"}], "brand_name": "Dexamethasone", "product_id": "72578-166_57d9469e-8d0d-4a58-a56c-3c266fe36b74", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "72578-166", "generic_name": "Dexamethasone", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "1 mg/1"}], "application_number": "ANDA216284", "marketing_category": "ANDA", "marketing_start_date": "20240513", "listing_expiration_date": "20261231"}