dexamethasone sodium phosphate (67457-483)

Drug Facts

Product Profile

Brand Name dexamethasone sodium phosphate

Generic Name dexamethasone sodium phosphate

Labeler mylan institutional llc

Dosage Form INJECTION, SOLUTION

Routes

INTRAMUSCULAR INTRAVENOUS

Active Ingredients

dexamethasone sodium phosphate 10 mg/mL

Manufacturer

Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-483

Product ID 67457-483_178a2eca-55c3-4ce9-8388-05a6469f120e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040802

Listing Expiration 2027-12-31

Marketing Start 2020-04-15

Pharmacologic Class

Classes

corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457483

Hyphenated Format 67457-483

Supplemental Identifiers

RxCUI

309696 1116927 1812194

UNII

AI9376Y64P

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 sodium phosphate (source: ndc)

Generic Name dexamethasone sodium phosphate (source: ndc)

Application Number ANDA040802 (source: ndc)

Routes

INTRAMUSCULAR INTRAVENOUS

source: ndc

Resolved Composition

Strengths

10 mg/mL

source: ndc

Packaging

10 VIAL in 1 CARTON (67457-483-10) / 10 mL in 1 VIAL (67457-483-00)

source: ndc

Packages (1)

67457-483-10 10 VIAL in 1 CARTON (67457-483-10) / 10 mL in 1 VIAL (67457-483-00)

Ingredients (1)

dexamethasone sodium phosphate (10 mg/mL)

Linked Drug Pages (1)

Dexamethasone Sodium Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "178a2eca-55c3-4ce9-8388-05a6469f120e", "openfda": {"unii": ["AI9376Y64P"], "rxcui": ["309696", "1116927", "1812194"], "spl_set_id": ["836f8017-d023-410b-8515-ec776e73ca59"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (67457-483-10)  / 10 mL in 1 VIAL (67457-483-00)", "package_ndc": "67457-483-10", "marketing_start_date": "20200415"}], "brand_name": "Dexamethasone Sodium Phosphate", "product_id": "67457-483_178a2eca-55c3-4ce9-8388-05a6469f120e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "67457-483", "generic_name": "Dexamethasone Sodium Phosphate", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone Sodium Phosphate", "active_ingredients": [{"name": "DEXAMETHASONE SODIUM PHOSPHATE", "strength": "10 mg/mL"}], "application_number": "ANDA040802", "marketing_category": "ANDA", "marketing_start_date": "20200415", "listing_expiration_date": "20271231"}