dexamethasone sodium phosphate (76420-398)

Drug Facts

Product Profile

Brand Name dexamethasone sodium phosphate

Generic Name dexamethasone sodium phosphate

Labeler asclemed usa, inc.

Dosage Form INJECTION, SOLUTION

Routes

INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR INTRAVENOUS SOFT TISSUE

Active Ingredients

dexamethasone sodium phosphate 4 mg/mL

Manufacturer

Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-398

Product ID 76420-398_36e3b30e-3943-244e-e063-6394a90aba7d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040803

Listing Expiration 2026-12-31

Marketing Start 2011-05-11

Pharmacologic Class

Classes

corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420398

Hyphenated Format 76420-398

Supplemental Identifiers

RxCUI

309696 1116927 1812194

UNII

AI9376Y64P

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 (76420-398-30) / 30 mL in 1 VIAL

source: ndc

Packages (1)

76420-398-30 25 VIAL in 1 CARTON (76420-398-30) / 30 mL in 1 VIAL

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": "36e3b30e-3943-244e-e063-6394a90aba7d", "openfda": {"unii": ["AI9376Y64P"], "rxcui": ["309696", "1116927", "1812194"], "spl_set_id": ["36854dbc-22f2-5df9-e063-6394a90ad934"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (76420-398-30)  / 30 mL in 1 VIAL", "package_ndc": "76420-398-30", "marketing_start_date": "20250531"}], "brand_name": "Dexamethasone Sodium Phosphate", "product_id": "76420-398_36e3b30e-3943-244e-e063-6394a90aba7d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "76420-398", "generic_name": "Dexamethasone Sodium Phosphate", "labeler_name": "Asclemed USA, Inc.", "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_start_date": "20110511", "listing_expiration_date": "20261231"}