dexamethasone

Generic: dexamethasone

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexamethasone
Generic Name dexamethasone
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexamethasone 4 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-561
Product ID 63187-561_64c0e623-ed7a-4168-83e4-8cd3905d06aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084612
Listing Expiration 2026-12-31
Marketing Start 1978-07-19

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 63187561
Hyphenated Format 63187-561

Supplemental Identifiers

RxCUI
197582
UPC
0363187561154
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 ANDA084612 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (63187-561-00)
  • 10 TABLET in 1 BOTTLE, PLASTIC (63187-561-10)
  • 15 TABLET in 1 BOTTLE, PLASTIC (63187-561-15)
  • 24 TABLET in 1 BOTTLE, PLASTIC (63187-561-24)
  • 30 TABLET in 1 BOTTLE, PLASTIC (63187-561-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (63187-561-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (63187-561-90)
source: ndc

Packages (7)

63187-561-00 100 TABLET in 1 BOTTLE, PLASTIC (63187-561-00) 63187-561-10 10 TABLET in 1 BOTTLE, PLASTIC (63187-561-10) 63187-561-15 15 TABLET in 1 BOTTLE, PLASTIC (63187-561-15) 63187-561-24 24 TABLET in 1 BOTTLE, PLASTIC (63187-561-24) 63187-561-30 30 TABLET in 1 BOTTLE, PLASTIC (63187-561-30) 63187-561-60 60 TABLET in 1 BOTTLE, PLASTIC (63187-561-60) 63187-561-90 90 TABLET in 1 BOTTLE, PLASTIC (63187-561-90)

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": "64c0e623-ed7a-4168-83e4-8cd3905d06aa", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0363187561154"], "unii": ["7S5I7G3JQL"], "rxcui": ["197582"], "spl_set_id": ["99296e80-3ca6-4430-9ef7-adca357c31b3"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (63187-561-00)", "package_ndc": "63187-561-00", "marketing_start_date": "20151001"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (63187-561-10)", "package_ndc": "63187-561-10", "marketing_start_date": "20161003"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (63187-561-15)", "package_ndc": "63187-561-15", "marketing_start_date": "20190901"}, {"sample": false, "description": "24 TABLET in 1 BOTTLE, PLASTIC (63187-561-24)", "package_ndc": "63187-561-24", "marketing_start_date": "20151001"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (63187-561-30)", "package_ndc": "63187-561-30", "marketing_start_date": "20151001"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (63187-561-60)", "package_ndc": "63187-561-60", "marketing_start_date": "20151001"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (63187-561-90)", "package_ndc": "63187-561-90", "marketing_start_date": "20151001"}], "brand_name": "Dexamethasone", "product_id": "63187-561_64c0e623-ed7a-4168-83e4-8cd3905d06aa", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "63187-561", "generic_name": "Dexamethasone", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "4 mg/1"}], "application_number": "ANDA084612", "marketing_category": "ANDA", "marketing_start_date": "19780719", "listing_expiration_date": "20261231"}