sodium phenylacetate and sodium benzoate

Generic: sodium phenylacetate and sodium benzoate

Labeler: omnivium pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium phenylacetate and sodium benzoate
Generic Name sodium phenylacetate and sodium benzoate
Labeler omnivium pharmaceuticals llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

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

Manufacturer
Omnivium Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 81665-204
Product ID 81665-204_03dcc78e-b47c-46dc-b7be-b6e6dcb0d071
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207096
Listing Expiration 2026-12-31
Marketing Start 2025-05-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81665204
Hyphenated Format 81665-204

Supplemental Identifiers

RxCUI
984118
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 ANDA207096 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (81665-204-01) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

81665-204-01 1 VIAL, SINGLE-DOSE in 1 CARTON (81665-204-01) / 50 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": "03dcc78e-b47c-46dc-b7be-b6e6dcb0d071", "openfda": {"unii": ["OJ245FE5EU", "48N6U1781G"], "rxcui": ["984118"], "spl_set_id": ["8fafc39b-69db-40f3-8a09-ee859e8cef19"], "manufacturer_name": ["Omnivium Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (81665-204-01)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "81665-204-01", "marketing_start_date": "20250515"}], "brand_name": "SODIUM PHENYLACETATE and SODIUM BENZOATE", "product_id": "81665-204_03dcc78e-b47c-46dc-b7be-b6e6dcb0d071", "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": "81665-204", "generic_name": "sodium phenylacetate and sodium benzoate", "labeler_name": "Omnivium Pharmaceuticals 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": "ANDA207096", "marketing_category": "ANDA", "marketing_start_date": "20250515", "listing_expiration_date": "20261231"}