dexamethasone sodium phosphate
Generic: dexamethasone sodium phosphate
Labeler: fresenius kabi usa, llcDrug Facts
Product Profile
Brand Name
dexamethasone sodium phosphate
Generic Name
dexamethasone sodium phosphate
Labeler
fresenius kabi usa, llc
Dosage Form
INJECTION, SOLUTION
Routes
Active Ingredients
dexamethasone sodium phosphate 4 mg/mL
Manufacturer
Identifiers & Regulatory
Product NDC
76045-106
Product ID
76045-106_f5934e17-4553-425b-b1bf-140cba479c36
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA203129
Listing Expiration
2027-12-31
Marketing Start
2015-10-30
Pharmacologic Class
Classes
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
76045106
Hyphenated Format
76045-106
Supplemental Identifiers
RxCUI
UNII
Packaging Origin
Original Packager
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
ANDA203129 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 4 mg/mL
Packaging
- HOW SUPPLIED/STORAGE AND HANDLING Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL is available as: 4 mg/mL in a 1 mL pre-filled disposable single-use syringe (NDC 76045-210-00). Available in a carton of twenty-four (24) syringes. NDC 76045-210-10. This product contains an RFID. 4 mg/mL in a 1 mL pre-filled disposable single-use syringe, NDC 76045-106-10 Available in a carton of twenty-four (24) syringes. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Protect from light. Sensitive to heat – Do not autoclave. Do not place syringe on a sterile field.
- PACKAGE LABEL - PRINCIPAL DISPLAY – Dexamethasone 1 mL Carton Panel Rx only NDC 76045-106-10 Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL For Intravenous or Intramuscular Use. Do NOT place syringe on a Sterile Field. 24 X 1 mL prefilled single use syringes Discard unused portion. PACKAGE LABEL - PRINCIPAL DISPLAY – Dexamethasone 1 mL Carton Panel
- PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 1 mL Blister Pack Label Rx only NDC 76045-106-10 Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL For IV or IM use. 1mL Prefilled single-use syringe PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 1 mL Blister Pack Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 1 mL Syringe Label 1mL Single-use. For IV or IM use. Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Dexamethasone 1 mL Syringe Label
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRA-ARTICULAR", "INTRALESIONAL", "INTRAMUSCULAR", "INTRAVENOUS", "SOFT TISSUE"], "spl_id": "f5934e17-4553-425b-b1bf-140cba479c36", "openfda": {"unii": ["AI9376Y64P"], "rxcui": ["1812095"], "spl_set_id": ["88d25d19-acff-477b-86c8-9797782045b8"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Dexamethasone Sodium Phosphate", "product_id": "76045-106_f5934e17-4553-425b-b1bf-140cba479c36", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "76045-106", "generic_name": "Dexamethasone Sodium Phosphate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone Sodium Phosphate", "active_ingredients": [{"name": "DEXAMETHASONE SODIUM PHOSPHATE", "strength": "4 mg/mL"}], "application_number": "ANDA203129", "marketing_category": "ANDA", "marketing_start_date": "20151030", "listing_expiration_date": "20271231"}