dexamethasone sodium phosphate

Generic: dexamethasone sodium phosphate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexamethasone sodium phosphate
Generic Name dexamethasone sodium phosphate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

dexamethasone sodium phosphate 10 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-0367
Product ID 0641-0367_02bf3273-f0c8-448c-9f74-eb009fee9299
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087702
Listing Expiration 2027-12-31
Marketing Start 1982-09-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06410367
Hyphenated Format 0641-0367

Supplemental Identifiers

RxCUI
309696 1116927 1812194
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 ANDA087702 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0641-0367-25) / 1 mL in 1 VIAL (0641-0367-21)
source: ndc

Packages (1)

0641-0367-25 25 VIAL in 1 CARTON (0641-0367-25) / 1 mL in 1 VIAL (0641-0367-21)

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": "02bf3273-f0c8-448c-9f74-eb009fee9299", "openfda": {"unii": ["AI9376Y64P"], "rxcui": ["309696", "1116927", "1812194"], "spl_set_id": ["0277cc0a-2fd4-4605-a310-b613be84ee26"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0641-0367-25)  / 1 mL in 1 VIAL (0641-0367-21)", "package_ndc": "0641-0367-25", "marketing_start_date": "19820907"}], "brand_name": "Dexamethasone Sodium Phosphate", "product_id": "0641-0367_02bf3273-f0c8-448c-9f74-eb009fee9299", "dosage_form": "INJECTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0641-0367", "generic_name": "Dexamethasone Sodium Phosphate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone Sodium Phosphate", "active_ingredients": [{"name": "DEXAMETHASONE SODIUM PHOSPHATE", "strength": "10 mg/mL"}], "application_number": "ANDA087702", "marketing_category": "ANDA", "marketing_start_date": "19820907", "listing_expiration_date": "20271231"}