dexamethasone intensol

Generic: dexamethasone intensol

Labeler: hikma pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexamethasone intensol
Generic Name dexamethasone intensol
Labeler hikma pharmaceuticals usa, inc.
Dosage Form SOLUTION, CONCENTRATE
Routes
ORAL
Active Ingredients

dexamethasone 1 mg/mL

Manufacturer
Hikma Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0054-3176
Product ID 0054-3176_286734bc-8329-4f44-a20b-610cf7b67591
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088252
Listing Expiration 2026-12-31
Marketing Start 1983-09-01

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 00543176
Hyphenated Format 0054-3176

Supplemental Identifiers

RxCUI
197577 197579 197580 197581 197582 197583 309684 309686 343033
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 intensol (source: ndc)
Generic Name dexamethasone intensol (source: ndc)
Application Number ANDA088252 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, GLASS (0054-3176-44)
source: ndc

Packages (1)

0054-3176-44 30 mL in 1 BOTTLE, GLASS (0054-3176-44)

Ingredients (1)

dexamethasone (1 mg/mL)

Linked Drug Pages (1)

Dexamethasone Intensol, Dexamethasone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "286734bc-8329-4f44-a20b-610cf7b67591", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL"], "rxcui": ["197577", "197579", "197580", "197581", "197582", "197583", "309684", "309686", "343033"], "spl_set_id": ["b15200fb-1826-472b-a907-e677a272513b"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, GLASS (0054-3176-44)", "package_ndc": "0054-3176-44", "marketing_start_date": "19830901"}], "brand_name": "Dexamethasone Intensol", "product_id": "0054-3176_286734bc-8329-4f44-a20b-610cf7b67591", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0054-3176", "generic_name": "Dexamethasone Intensol", "labeler_name": "Hikma Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone Intensol", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "1 mg/mL"}], "application_number": "ANDA088252", "marketing_category": "ANDA", "marketing_start_date": "19830901", "listing_expiration_date": "20261231"}