dexamethasone

Generic: dexamethasone

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

Drug Facts

Product Profile

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

dexamethasone 1.5 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0346
Product ID 80425-0346_4250a0b0-e539-57c9-e063-6294a90a4b55
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201270
Listing Expiration 2026-12-31
Marketing Start 2023-07-31

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 804250346
Hyphenated Format 80425-0346

Supplemental Identifiers

RxCUI
197580
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 ANDA201270 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 21 TABLET in 1 BOTTLE (80425-0346-1)
  • 27 TABLET in 1 BOTTLE (80425-0346-2)
  • 49 TABLET in 1 BOTTLE (80425-0346-3)
  • 60 TABLET in 1 BOTTLE (80425-0346-4)
source: ndc

Packages (4)

80425-0346-1 21 TABLET in 1 BOTTLE (80425-0346-1) 80425-0346-2 27 TABLET in 1 BOTTLE (80425-0346-2) 80425-0346-3 49 TABLET in 1 BOTTLE (80425-0346-3) 80425-0346-4 60 TABLET in 1 BOTTLE (80425-0346-4)

Ingredients (1)

dexamethasone (1.5 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": "4250a0b0-e539-57c9-e063-6294a90a4b55", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL"], "rxcui": ["197580"], "spl_set_id": ["01cfaa3e-5e30-18fa-e063-6394a90a084e"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET in 1 BOTTLE (80425-0346-1)", "package_ndc": "80425-0346-1", "marketing_start_date": "20230731"}, {"sample": false, "description": "27 TABLET in 1 BOTTLE (80425-0346-2)", "package_ndc": "80425-0346-2", "marketing_start_date": "20230731"}, {"sample": false, "description": "49 TABLET in 1 BOTTLE (80425-0346-3)", "package_ndc": "80425-0346-3", "marketing_start_date": "20230731"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0346-4)", "package_ndc": "80425-0346-4", "marketing_start_date": "20251028"}], "brand_name": "Dexamethasone", "product_id": "80425-0346_4250a0b0-e539-57c9-e063-6294a90a4b55", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "80425-0346", "generic_name": "Dexamethasone", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "1.5 mg/1"}], "application_number": "ANDA201270", "marketing_category": "ANDA", "marketing_start_date": "20230731", "listing_expiration_date": "20261231"}