dexamethasone sodium phosphate (67457-418)

Drug Facts

Product Profile

Brand Name dexamethasone sodium phosphate

Generic Name dexamethasone sodium phosphate

Labeler mylan institutional llc

Dosage Form INJECTION, SOLUTION

Routes

INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR INTRAVENOUS SOFT TISSUE

Active Ingredients

dexamethasone sodium phosphate 4 mg/mL

Manufacturer

Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-418

Product ID 67457-418_178a2eca-55c3-4ce9-8388-05a6469f120e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040803

Marketing Start 2020-04-15

Marketing End 2026-10-31

Pharmacologic Class

Classes

corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457418

Hyphenated Format 67457-418

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 ANDA040803 (source: ndc)

Routes

INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR INTRAVENOUS SOFT TISSUE

source: ndc

Resolved Composition

Strengths

4 mg/mL

source: ndc

Packaging

25 VIAL in 1 CARTON (67457-418-05) / 5 mL in 1 VIAL (67457-418-00)

source: ndc

Packages (1)

67457-418-05 25 VIAL in 1 CARTON (67457-418-05) / 5 mL in 1 VIAL (67457-418-00)

Ingredients (1)

dexamethasone sodium phosphate (4 mg/mL)

Linked Drug Pages (1)

Dexamethasone Sodium Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRA-ARTICULAR", "INTRALESIONAL", "INTRAMUSCULAR", "INTRAVENOUS", "SOFT TISSUE"], "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": "25 VIAL in 1 CARTON (67457-418-05)  / 5 mL in 1 VIAL (67457-418-00)", "package_ndc": "67457-418-05", "marketing_end_date": "20261031", "marketing_start_date": "20200415"}], "brand_name": "Dexamethasone Sodium Phosphate", "product_id": "67457-418_178a2eca-55c3-4ce9-8388-05a6469f120e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "67457-418", "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": "4 mg/mL"}], "application_number": "ANDA040803", "marketing_category": "ANDA", "marketing_end_date": "20261031", "marketing_start_date": "20200415"}