sodium phenylacetate and sodium benzoate (68475-513)

Drug Facts

Product Profile

Brand Name sodium phenylacetate and sodium benzoate

Generic Name sodium phenylacetate and sodium benzoate

Labeler navinta llc

Dosage Form INJECTION, SOLUTION, CONCENTRATE

Routes

INTRAVENOUS

Active Ingredients

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

Manufacturer

Navinta LLC

Identifiers & Regulatory

Product NDC 68475-513

Product ID 68475-513_1c41d0b4-cb49-468a-a9f3-6eeb22dd836f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA217526

Listing Expiration 2026-12-31

Marketing Start 2025-12-06

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68475513

Hyphenated Format 68475-513

Supplemental Identifiers

RxCUI

2560228

UPC

0368475513013

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 ANDA217526 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

100 mg/mL

source: ndc

Packaging

1 VIAL in 1 CARTON (68475-513-01) / 20 mL in 1 VIAL

source: ndc

Packages (1)

68475-513-01 1 VIAL in 1 CARTON (68475-513-01) / 20 mL in 1 VIAL

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": "1c41d0b4-cb49-468a-a9f3-6eeb22dd836f", "openfda": {"upc": ["0368475513013"], "unii": ["OJ245FE5EU", "48N6U1781G"], "rxcui": ["2560228"], "spl_set_id": ["d20768fe-4516-483a-a082-ff1df9ad1d99"], "manufacturer_name": ["Navinta LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68475-513-01)  / 20 mL in 1 VIAL", "package_ndc": "68475-513-01", "marketing_start_date": "20251206"}], "brand_name": "Sodium phenylacetate and Sodium benzoate", "product_id": "68475-513_1c41d0b4-cb49-468a-a9f3-6eeb22dd836f", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Ammonium Ion Binding Activity [MoA]", "Ammonium Ion Binding Activity [MoA]", "Nitrogen Binding Agent [EPC]", "Nitrogen Binding Agent [EPC]"], "product_ndc": "68475-513", "generic_name": "Sodium phenylacetate and Sodium benzoate", "labeler_name": "Navinta LLC", "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": "ANDA217526", "marketing_category": "ANDA", "marketing_start_date": "20251206", "listing_expiration_date": "20261231"}