sodium phenylacetate and sodium benzoate

Generic: sodium phenylacetate and sodium benzoate

Labeler: fosun pharma usa inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium phenylacetate and sodium benzoate
Generic Name sodium phenylacetate and sodium benzoate
Labeler fosun pharma usa inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

sodium benzoate 100 mg/mL, sodium phenylacetate 100 mg/mL

Manufacturer
FOSUN PHARMA USA INC

Identifiers & Regulatory

Product NDC 72266-236
Product ID 72266-236_18084634-4c12-58ee-e063-6294a90ac7d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215025
Listing Expiration 2026-12-31
Marketing Start 2021-11-14

Pharmacologic Class

Classes
ammonium ion binding activity [moa] nitrogen binding agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72266236
Hyphenated Format 72266-236

Supplemental Identifiers

RxCUI
2560228
UNII
OJ245FE5EU 48N6U1781G

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 sodium phenylacetate and sodium benzoate (source: ndc)
Generic Name sodium phenylacetate and sodium benzoate (source: ndc)
Application Number NDA215025 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (72266-236-01) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

72266-236-01 1 VIAL, SINGLE-DOSE in 1 CARTON (72266-236-01) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

sodium benzoate (100 mg/mL) sodium phenylacetate (100 mg/mL)

Linked Drug Pages (1)

Sodium Phenylacetate and Sodium Benzoate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "18084634-4c12-58ee-e063-6294a90ac7d3", "openfda": {"unii": ["OJ245FE5EU", "48N6U1781G"], "rxcui": ["2560228"], "spl_set_id": ["cee1e9a2-bbe5-2419-e053-2a95a90ac3ef"], "manufacturer_name": ["FOSUN PHARMA USA INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (72266-236-01)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "72266-236-01", "marketing_start_date": "20211114"}], "brand_name": "Sodium Phenylacetate and Sodium Benzoate", "product_id": "72266-236_18084634-4c12-58ee-e063-6294a90ac7d3", "dosage_form": "INJECTION", "pharm_class": ["Ammonium Ion Binding Activity [MoA]", "Ammonium Ion Binding Activity [MoA]", "Nitrogen Binding Agent [EPC]", "Nitrogen Binding Agent [EPC]"], "product_ndc": "72266-236", "generic_name": "Sodium Phenylacetate and Sodium Benzoate", "labeler_name": "FOSUN PHARMA USA INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Phenylacetate and Sodium Benzoate", "active_ingredients": [{"name": "SODIUM BENZOATE", "strength": "100 mg/mL"}, {"name": "SODIUM PHENYLACETATE", "strength": "100 mg/mL"}], "application_number": "NDA215025", "marketing_category": "NDA", "marketing_start_date": "20211114", "listing_expiration_date": "20261231"}