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, EMULSION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

dexamethasone sodium phosphate 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 76045-109
Product ID 76045-109_6fd9ed0e-dddc-4e73-9442-49da54685f7b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209192
Listing Expiration 2027-12-31
Marketing Start 2018-07-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76045109
Hyphenated Format 76045-109

Supplemental Identifiers

RxCUI
2099700
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 ANDA209192 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 24 BLISTER PACK in 1 CARTON (76045-109-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (76045-109-01)
source: ndc

Packages (1)

76045-109-10 24 BLISTER PACK in 1 CARTON (76045-109-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (76045-109-01)

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": "6fd9ed0e-dddc-4e73-9442-49da54685f7b", "openfda": {"unii": ["AI9376Y64P"], "rxcui": ["2099700"], "spl_set_id": ["4dd55929-fe0a-4884-ae0d-6f9435920eb7"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BLISTER PACK in 1 CARTON (76045-109-10)  / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (76045-109-01)", "package_ndc": "76045-109-10", "marketing_start_date": "20180706"}], "brand_name": "Dexamethasone Sodium Phosphate", "product_id": "76045-109_6fd9ed0e-dddc-4e73-9442-49da54685f7b", "dosage_form": "INJECTION, EMULSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "76045-109", "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": "ANDA209192", "marketing_category": "ANDA", "marketing_start_date": "20180706", "listing_expiration_date": "20271231"}