dexamethasone sodium phosphate (68083-607)

Drug Facts

Product Profile

Brand Name dexamethasone sodium phosphate

Generic Name dexamethasone sodium phosphate

Labeler gland pharma limited

Dosage Form INJECTION

Routes

INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR INTRAVENOUS SOFT TISSUE

Active Ingredients

dexamethasone sodium phosphate 10 mg/mL

Manufacturer

Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-607

Product ID 68083-607_0ca8b553-e90b-4049-8c44-35b876d8f186

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA215654

Listing Expiration 2026-12-31

Marketing Start 2023-09-25

Pharmacologic Class

Classes

corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083607

Hyphenated Format 68083-607

Supplemental Identifiers

RxCUI

1116927 1812079 1812194

UPC

0368083473259

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 ANDA215654 (source: ndc)

Routes

INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR INTRAVENOUS SOFT TISSUE

source: ndc

Resolved Composition

Strengths

10 mg/mL

source: ndc

Packaging

25 VIAL, SINGLE-DOSE in 1 CARTON (68083-607-25) / 1 mL in 1 VIAL, SINGLE-DOSE (68083-607-01)

source: ndc

Packages (1)

68083-607-25 25 VIAL, SINGLE-DOSE in 1 CARTON (68083-607-25) / 1 mL in 1 VIAL, SINGLE-DOSE (68083-607-01)

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": ["INTRA-ARTICULAR", "INTRALESIONAL", "INTRAMUSCULAR", "INTRAVENOUS", "SOFT TISSUE"], "spl_id": "0ca8b553-e90b-4049-8c44-35b876d8f186", "openfda": {"upc": ["0368083473259"], "unii": ["AI9376Y64P"], "rxcui": ["1116927", "1812079", "1812194"], "spl_set_id": ["c9d9ab76-6bc6-433d-aad7-8d49064ed745"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (68083-607-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (68083-607-01)", "package_ndc": "68083-607-25", "marketing_start_date": "20230925"}], "brand_name": "Dexamethasone Sodium Phosphate", "product_id": "68083-607_0ca8b553-e90b-4049-8c44-35b876d8f186", "dosage_form": "INJECTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68083-607", "generic_name": "Dexamethasone Sodium Phosphate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone Sodium Phosphate", "active_ingredients": [{"name": "DEXAMETHASONE SODIUM PHOSPHATE", "strength": "10 mg/mL"}], "application_number": "ANDA215654", "marketing_category": "ANDA", "marketing_start_date": "20230925", "listing_expiration_date": "20261231"}