dexamethasone sodium phosphate

Generic: dexamethasone sodium phosphate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexamethasone sodium phosphate
Generic Name dexamethasone sodium phosphate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

dexamethasone sodium phosphate 4 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-165
Product ID 63323-165_a832bff9-0bb3-4350-abb5-d57b9417070c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084916
Listing Expiration 2026-12-31
Marketing Start 2000-09-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323165
Hyphenated Format 63323-165

Supplemental Identifiers

RxCUI
1116927 1812194
UPC
0363323165024 0363323165130 0363323165031 0363323165116 0363323165307
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 ANDA084916 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (63323-165-01) / 1 mL in 1 VIAL (63323-165-02)
  • 25 VIAL, MULTI-DOSE in 1 TRAY (63323-165-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-165-03)
  • 1 VIAL, MULTI-DOSE in 1 BOX (63323-165-30) / 30 mL in 1 VIAL, MULTI-DOSE
  • 25 VIAL in 1 TRAY (63323-165-51) / 1 mL in 1 VIAL (63323-165-11)
  • 25 VIAL, MULTI-DOSE in 1 TRAY (63323-165-53) / 5 mL in 1 VIAL, MULTI-DOSE (63323-165-13)
source: ndc

Packages (5)

63323-165-01 25 VIAL in 1 TRAY (63323-165-01) / 1 mL in 1 VIAL (63323-165-02) 63323-165-05 25 VIAL, MULTI-DOSE in 1 TRAY (63323-165-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-165-03) 63323-165-30 1 VIAL, MULTI-DOSE in 1 BOX (63323-165-30) / 30 mL in 1 VIAL, MULTI-DOSE 63323-165-51 25 VIAL in 1 TRAY (63323-165-51) / 1 mL in 1 VIAL (63323-165-11) 63323-165-53 25 VIAL, MULTI-DOSE in 1 TRAY (63323-165-53) / 5 mL in 1 VIAL, MULTI-DOSE (63323-165-13)

Ingredients (1)

dexamethasone sodium phosphate (4 mg/mL)

Linked Drug Pages (2)

Dexamethasone Sodium Phosphate ndc-match (0.9) Dexamethasone Sodium Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "a832bff9-0bb3-4350-abb5-d57b9417070c", "openfda": {"upc": ["0363323165024", "0363323165130", "0363323165031", "0363323165116", "0363323165307"], "unii": ["AI9376Y64P"], "rxcui": ["1116927", "1812194"], "spl_set_id": ["2b626a48-c7aa-4443-9164-a08ff069ccd1"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (63323-165-01)  / 1 mL in 1 VIAL (63323-165-02)", "package_ndc": "63323-165-01", "marketing_start_date": "20000907"}, {"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-165-05)  / 5 mL in 1 VIAL, MULTI-DOSE (63323-165-03)", "package_ndc": "63323-165-05", "marketing_start_date": "20000907"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BOX (63323-165-30)  / 30 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-165-30", "marketing_start_date": "20000907"}, {"sample": false, "description": "25 VIAL in 1 TRAY (63323-165-51)  / 1 mL in 1 VIAL (63323-165-11)", "package_ndc": "63323-165-51", "marketing_start_date": "20250217"}, {"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-165-53)  / 5 mL in 1 VIAL, MULTI-DOSE (63323-165-13)", "package_ndc": "63323-165-53", "marketing_start_date": "20250217"}], "brand_name": "Dexamethasone Sodium Phosphate", "product_id": "63323-165_a832bff9-0bb3-4350-abb5-d57b9417070c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "63323-165", "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": "ANDA084916", "marketing_category": "ANDA", "marketing_start_date": "20000907", "listing_expiration_date": "20261231"}