sodium phenylbutyrate

Generic: sodium phenylbutyrate

Labeler: sigmapharm laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium phenylbutyrate
Generic Name sodium phenylbutyrate
Labeler sigmapharm laboratories, llc
Dosage Form POWDER
Routes
ORAL
Active Ingredients

sodium phenylbutyrate .94 g/g

Manufacturer
Sigmapharm Laboratories, LLC

Identifiers & Regulatory

Product NDC 42794-086
Product ID 42794-086_d70f7f7c-f27a-db94-e053-2995a90a6937
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202819
Listing Expiration 2026-12-31
Marketing Start 2013-04-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42794086
Hyphenated Format 42794-086

Supplemental Identifiers

RxCUI
984105
UPC
0342794086144
UNII
NT6K61736T

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 phenylbutyrate (source: ndc)
Generic Name sodium phenylbutyrate (source: ndc)
Application Number ANDA202819 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .94 g/g
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (42794-086-14) / 250 g in 1 BOTTLE
source: ndc

Packages (1)

42794-086-14 1 BOTTLE in 1 CARTON (42794-086-14) / 250 g in 1 BOTTLE

Ingredients (1)

sodium phenylbutyrate (.94 g/g)

Linked Drug Pages (1)

Sodium Phenylbutyrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d70f7f7c-f27a-db94-e053-2995a90a6937", "openfda": {"upc": ["0342794086144"], "unii": ["NT6K61736T"], "rxcui": ["984105"], "spl_set_id": ["e914d451-6122-43f9-af8d-c80ed1cb215d"], "manufacturer_name": ["Sigmapharm Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (42794-086-14)  / 250 g in 1 BOTTLE", "package_ndc": "42794-086-14", "marketing_start_date": "20130408"}], "brand_name": "Sodium Phenylbutyrate", "product_id": "42794-086_d70f7f7c-f27a-db94-e053-2995a90a6937", "dosage_form": "POWDER", "pharm_class": ["Ammonium Ion Binding Activity [MoA]", "Nitrogen Binding Agent [EPC]"], "product_ndc": "42794-086", "generic_name": "Sodium Phenylbutyrate", "labeler_name": "Sigmapharm Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Phenylbutyrate", "active_ingredients": [{"name": "SODIUM PHENYLBUTYRATE", "strength": ".94 g/g"}], "application_number": "ANDA202819", "marketing_category": "ANDA", "marketing_start_date": "20130408", "listing_expiration_date": "20261231"}