dexamethasone

Generic: dexamethasone

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexamethasone
Generic Name dexamethasone
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexamethasone 4 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0515
Product ID 80425-0515_348f5a61-1623-3f2f-e063-6394a90addbe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217001
Listing Expiration 2026-12-31
Marketing Start 2025-05-07

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 804250515
Hyphenated Format 80425-0515

Supplemental Identifiers

RxCUI
197582
UNII
7S5I7G3JQL
NUI
N0000175576 N0000175450

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 ANDA217001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 12 TABLET in 1 BOTTLE (80425-0515-1)
source: ndc

Packages (1)

80425-0515-1 12 TABLET in 1 BOTTLE (80425-0515-1)

Ingredients (1)

dexamethasone (4 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": "348f5a61-1623-3f2f-e063-6394a90addbe", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL"], "rxcui": ["197582"], "spl_set_id": ["348f5a56-978d-4272-e063-6294a90afdb6"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET in 1 BOTTLE (80425-0515-1)", "package_ndc": "80425-0515-1", "marketing_start_date": "20250507"}], "brand_name": "Dexamethasone", "product_id": "80425-0515_348f5a61-1623-3f2f-e063-6394a90addbe", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "80425-0515", "generic_name": "Dexamethasone", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "4 mg/1"}], "application_number": "ANDA217001", "marketing_category": "ANDA", "marketing_start_date": "20250507", "listing_expiration_date": "20261231"}