sodium phenylbutyrate

Generic: sodium phenylbutyrate tablets, 500 mg

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

Drug Facts

Product Profile

Brand Name sodium phenylbutyrate
Generic Name sodium phenylbutyrate tablets, 500 mg
Labeler endo usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sodium phenylbutyrate 500 mg/1

Manufacturer
ENDO USA, Inc.

Identifiers & Regulatory

Product NDC 49884-170
Product ID 49884-170_0aa4a079-431c-407a-a5e5-645a63020119
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204395
Listing Expiration 2026-12-31
Marketing Start 2016-04-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49884170
Hyphenated Format 49884-170

Supplemental Identifiers

RxCUI
199369
UPC
0349884170042
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 tablets, 500 mg (source: ndc)
Application Number ANDA204395 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (49884-170-04) / 250 TABLET in 1 BOTTLE
source: ndc

Packages (1)

49884-170-04 1 BOTTLE in 1 CARTON (49884-170-04) / 250 TABLET in 1 BOTTLE

Ingredients (1)

sodium phenylbutyrate (500 mg/1)

Linked Drug Pages (1)

Sodium Phenylbutyrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0aa4a079-431c-407a-a5e5-645a63020119", "openfda": {"upc": ["0349884170042"], "unii": ["NT6K61736T"], "rxcui": ["199369"], "spl_set_id": ["4020b962-eaee-4184-b04b-14ca757c51a1"], "manufacturer_name": ["ENDO USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (49884-170-04)  / 250 TABLET in 1 BOTTLE", "package_ndc": "49884-170-04", "marketing_start_date": "20160429"}], "brand_name": "Sodium Phenylbutyrate", "product_id": "49884-170_0aa4a079-431c-407a-a5e5-645a63020119", "dosage_form": "TABLET", "pharm_class": ["Ammonium Ion Binding Activity [MoA]", "Nitrogen Binding Agent [EPC]"], "product_ndc": "49884-170", "generic_name": "Sodium Phenylbutyrate Tablets, 500 mg", "labeler_name": "ENDO USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Phenylbutyrate", "active_ingredients": [{"name": "SODIUM PHENYLBUTYRATE", "strength": "500 mg/1"}], "application_number": "ANDA204395", "marketing_category": "ANDA", "marketing_start_date": "20160429", "listing_expiration_date": "20261231"}