dexamethasone sodium phosphate (63323-516)

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 10 mg/mL

Manufacturer

Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-516

Product ID 63323-516_9320abbb-bfd8-4df2-9269-3a52736c190f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040572

Listing Expiration 2027-12-31

Marketing Start 2005-04-05

Pharmacologic Class

Classes

corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323516

Hyphenated Format 63323-516

Supplemental Identifiers

RxCUI

309696 1812079

UPC

0363323506001 0363323516017 0363323506032

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 ANDA040572 (source: ndc)

Routes

INTRAMUSCULAR INTRAVENOUS

source: ndc

Resolved Composition

Strengths

10 mg/mL

source: ndc

Packaging

10 VIAL in 1 TRAY (63323-516-10) / 10 mL in 1 VIAL (63323-516-01)

source: ndc

Packages (1)

63323-516-10 10 VIAL in 1 TRAY (63323-516-10) / 10 mL in 1 VIAL (63323-516-01)

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": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "9320abbb-bfd8-4df2-9269-3a52736c190f", "openfda": {"upc": ["0363323506001", "0363323516017", "0363323506032"], "unii": ["AI9376Y64P"], "rxcui": ["309696", "1812079"], "spl_set_id": ["cca2c160-9188-48e8-9505-49a52388dcb7"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 TRAY (63323-516-10)  / 10 mL in 1 VIAL (63323-516-01)", "package_ndc": "63323-516-10", "marketing_start_date": "20050405"}], "brand_name": "Dexamethasone Sodium Phosphate", "product_id": "63323-516_9320abbb-bfd8-4df2-9269-3a52736c190f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "63323-516", "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": "10 mg/mL"}], "application_number": "ANDA040572", "marketing_category": "ANDA", "marketing_start_date": "20050405", "listing_expiration_date": "20271231"}