dexamethasone sodium phosphate

Generic: dexamethasone sodium phosphate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 4 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-474
Product ID 68083-474_0ca8b553-e90b-4049-8c44-35b876d8f186
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215654
Listing Expiration 2026-12-31
Marketing Start 2021-08-04

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083474
Hyphenated Format 68083-474

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
  • 4 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 CARTON (68083-474-25) / 5 mL in 1 VIAL, MULTI-DOSE (68083-474-01)
source: ndc

Packages (1)

68083-474-25 25 VIAL, MULTI-DOSE in 1 CARTON (68083-474-25) / 5 mL in 1 VIAL, MULTI-DOSE (68083-474-01)

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": "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, MULTI-DOSE in 1 CARTON (68083-474-25)  / 5 mL in 1 VIAL, MULTI-DOSE (68083-474-01)", "package_ndc": "68083-474-25", "marketing_start_date": "20210804"}], "brand_name": "Dexamethasone Sodium Phosphate", "product_id": "68083-474_0ca8b553-e90b-4049-8c44-35b876d8f186", "dosage_form": "INJECTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68083-474", "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": "4 mg/mL"}], "application_number": "ANDA215654", "marketing_category": "ANDA", "marketing_start_date": "20210804", "listing_expiration_date": "20261231"}