sodium phenylbutyrate

Generic: sodium phenylbutyrate

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium phenylbutyrate
Generic Name sodium phenylbutyrate
Labeler endo usa, inc.
Dosage Form POWDER
Routes
ORAL
Active Ingredients

sodium phenylbutyrate .94 g/g

Manufacturer
ENDO USA, Inc.

Identifiers & Regulatory

Product NDC 49884-006
Product ID 49884-006_f2c8509e-be24-4c67-b50e-7096ae15dd2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203918
Listing Expiration 2026-12-31
Marketing Start 2016-08-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49884006
Hyphenated Format 49884-006

Supplemental Identifiers

RxCUI
984105
UPC
0349884006044
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 ANDA203918 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .94 g/g
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (49884-006-04) / 250 g in 1 BOTTLE
source: ndc

Packages (1)

49884-006-04 1 BOTTLE in 1 CARTON (49884-006-04) / 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": "f2c8509e-be24-4c67-b50e-7096ae15dd2a", "openfda": {"upc": ["0349884006044"], "unii": ["NT6K61736T"], "rxcui": ["984105"], "spl_set_id": ["639f5c7e-9f6d-47fb-a417-2be076176a78"], "manufacturer_name": ["ENDO USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (49884-006-04)  / 250 g in 1 BOTTLE", "package_ndc": "49884-006-04", "marketing_start_date": "20160831"}], "brand_name": "Sodium Phenylbutyrate", "product_id": "49884-006_f2c8509e-be24-4c67-b50e-7096ae15dd2a", "dosage_form": "POWDER", "pharm_class": ["Ammonium Ion Binding Activity [MoA]", "Nitrogen Binding Agent [EPC]"], "product_ndc": "49884-006", "generic_name": "Sodium Phenylbutyrate", "labeler_name": "ENDO USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Phenylbutyrate", "active_ingredients": [{"name": "SODIUM PHENYLBUTYRATE", "strength": ".94 g/g"}], "application_number": "ANDA203918", "marketing_category": "ANDA", "marketing_start_date": "20160831", "listing_expiration_date": "20261231"}