sodium phenylacetate and sodium benzoate

Generic: sodium phenylacetate and sodium benzoate

Labeler: zydus pharmaceuticals usa inc.
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 zydus pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

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

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1926
Product ID 70710-1926_fd646c47-7fcd-4d60-8f6c-29e13f611c6d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217526
Listing Expiration 2026-12-31
Marketing Start 2023-09-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101926
Hyphenated Format 70710-1926

Supplemental Identifiers

RxCUI
2560228
UPC
0370710192617
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 (70710-1926-1) / 20 mL in 1 VIAL
source: ndc

Packages (1)

70710-1926-1 1 VIAL in 1 CARTON (70710-1926-1) / 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": "fd646c47-7fcd-4d60-8f6c-29e13f611c6d", "openfda": {"upc": ["0370710192617"], "unii": ["OJ245FE5EU", "48N6U1781G"], "rxcui": ["2560228"], "spl_set_id": ["0f17c50f-3761-4470-bf3b-63837a287b8a"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (70710-1926-1)  / 20 mL in 1 VIAL", "package_ndc": "70710-1926-1", "marketing_start_date": "20230919"}], "brand_name": "Sodium phenylacetate and Sodium benzoate", "product_id": "70710-1926_fd646c47-7fcd-4d60-8f6c-29e13f611c6d", "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": "70710-1926", "generic_name": "Sodium phenylacetate and Sodium benzoate", "labeler_name": "Zydus Pharmaceuticals 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": "ANDA217526", "marketing_category": "ANDA", "marketing_start_date": "20230919", "listing_expiration_date": "20261231"}