pheburane

Generic: sodium phenylbutyrate

Labeler: medunik usa
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pheburane
Generic Name sodium phenylbutyrate
Labeler medunik usa
Dosage Form PELLET
Routes
ORAL
Active Ingredients

sodium phenylbutyrate 483 mg/g

Manufacturer
Medunik USA

Identifiers & Regulatory

Product NDC 71770-210
Product ID 71770-210_4072f3df-e754-4c2e-be0c-af3c8edb9211
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216513
Listing Expiration 2026-12-31
Marketing Start 2022-09-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71770210
Hyphenated Format 71770-210

Supplemental Identifiers

RxCUI
2610128 2610134
UPC
0371770200106
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 pheburane (source: ndc)
Generic Name sodium phenylbutyrate (source: ndc)
Application Number NDA216513 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 483 mg/g
source: ndc
Packaging
  • 174 g in 1 BOTTLE (71770-210-10)
source: ndc

Packages (1)

71770-210-10 174 g in 1 BOTTLE (71770-210-10)

Ingredients (1)

sodium phenylbutyrate (483 mg/g)

Linked Drug Pages (1)

PHEBURANE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4072f3df-e754-4c2e-be0c-af3c8edb9211", "openfda": {"upc": ["0371770200106"], "unii": ["NT6K61736T"], "rxcui": ["2610128", "2610134"], "spl_set_id": ["d15f2cbf-4d22-40b5-8ef9-16b9d323a7f9"], "manufacturer_name": ["Medunik USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "174 g in 1 BOTTLE (71770-210-10)", "package_ndc": "71770-210-10", "marketing_start_date": "20220914"}], "brand_name": "PHEBURANE", "product_id": "71770-210_4072f3df-e754-4c2e-be0c-af3c8edb9211", "dosage_form": "PELLET", "pharm_class": ["Ammonium Ion Binding Activity [MoA]", "Nitrogen Binding Agent [EPC]"], "product_ndc": "71770-210", "generic_name": "Sodium phenylbutyrate", "labeler_name": "Medunik USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHEBURANE", "active_ingredients": [{"name": "SODIUM PHENYLBUTYRATE", "strength": "483 mg/g"}], "application_number": "NDA216513", "marketing_category": "NDA", "marketing_start_date": "20220914", "listing_expiration_date": "20261231"}