Package 68462-853-20
Brand: sodium phenylbutyrate
Generic: sodium phenylbutyratePackage Facts
Identity
Package NDC
68462-853-20
Digits Only
6846285320
Product NDC
68462-853
Description
250 TABLET in 1 BOTTLE (68462-853-20)
Marketing
Marketing Status
Brand
sodium phenylbutyrate
Generic
sodium phenylbutyrate
Sample Package
No
Linked Drug Pages (1)
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"}