sodium phenylbutyrate

Generic: sodium phenylbutyrate

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

Drug Facts

Product Profile

Brand Name sodium phenylbutyrate
Generic Name sodium phenylbutyrate
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sodium phenylbutyrate 500 mg/1

Manufacturer
GLENMARK PHARMACEUTICALS INC., USA

Identifiers & Regulatory

Product NDC 68462-853
Product ID 68462-853_060b5266-8881-4270-b62d-df8e49ecfd4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216462
Listing Expiration 2027-12-31
Marketing Start 2022-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462853
Hyphenated Format 68462-853

Supplemental Identifiers

RxCUI
199369
UPC
0368462853207
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 ANDA216462 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 250 TABLET in 1 BOTTLE (68462-853-20)
source: ndc

Packages (1)

68462-853-20 250 TABLET in 1 BOTTLE (68462-853-20)

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": "060b5266-8881-4270-b62d-df8e49ecfd4b", "openfda": {"upc": ["0368462853207"], "unii": ["NT6K61736T"], "rxcui": ["199369"], "spl_set_id": ["0c76d25b-abac-41a3-a547-4fa4796bf7a4"], "manufacturer_name": ["GLENMARK PHARMACEUTICALS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 TABLET in 1 BOTTLE (68462-853-20)", "package_ndc": "68462-853-20", "marketing_start_date": "20221101"}], "brand_name": "sodium phenylbutyrate", "product_id": "68462-853_060b5266-8881-4270-b62d-df8e49ecfd4b", "dosage_form": "TABLET", "pharm_class": ["Ammonium Ion Binding Activity [MoA]", "Nitrogen Binding Agent [EPC]"], "product_ndc": "68462-853", "generic_name": "sodium phenylbutyrate", "labeler_name": "GLENMARK PHARMACEUTICALS INC., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sodium phenylbutyrate", "active_ingredients": [{"name": "SODIUM PHENYLBUTYRATE", "strength": "500 mg/1"}], "application_number": "ANDA216462", "marketing_category": "ANDA", "marketing_start_date": "20221101", "listing_expiration_date": "20271231"}