sodium phenylacetate and sodium benzoate (70511-101)

Drug Facts

Product Profile

Brand Name sodium phenylacetate and sodium benzoate

Generic Name sodium phenylacetate and sodium benzoate

Labeler maia pharmaceuticals, inc

Dosage Form INJECTION, SOLUTION, CONCENTRATE

Routes

INTRAVENOUS

Active Ingredients

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

Manufacturer

MAIA PHARMACEUTICALS, INC

Identifiers & Regulatory

Product NDC 70511-101

Product ID 70511-101_c158c088-1ab5-4099-a174-96aba96feb11

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208521

Listing Expiration 2026-12-31

Marketing Start 2017-05-22

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70511101

Hyphenated Format 70511-101

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 ANDA208521 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

100 mg/mL

source: ndc

Packaging

1 VIAL, SINGLE-DOSE in 1 CARTON (70511-101-50) / 50 mL in 1 VIAL, SINGLE-DOSE

source: ndc

Packages (1)

70511-101-50 1 VIAL, SINGLE-DOSE in 1 CARTON (70511-101-50) / 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": "c158c088-1ab5-4099-a174-96aba96feb11", "openfda": {"unii": ["OJ245FE5EU", "48N6U1781G"], "rxcui": ["984118"], "spl_set_id": ["3529be10-0004-4628-9ca1-67a8acd86b51"], "manufacturer_name": ["MAIA PHARMACEUTICALS, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (70511-101-50)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70511-101-50", "marketing_start_date": "20170522"}], "brand_name": "SODIUM PHENYLACETATE AND SODIUM BENZOATE", "product_id": "70511-101_c158c088-1ab5-4099-a174-96aba96feb11", "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": "70511-101", "generic_name": "sodium phenylacetate and sodium benzoate", "labeler_name": "MAIA PHARMACEUTICALS, 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": "ANDA208521", "marketing_category": "ANDA", "marketing_start_date": "20170522", "listing_expiration_date": "20261231"}