Package 68135-058-90
Brand: palynziq
Generic: pegvaliase-pqpzPackage Facts
Identity
Package NDC
68135-058-90
Digits Only
6813505890
Product NDC
68135-058
Description
1 SYRINGE in 1 CARTON (68135-058-90) / .5 mL in 1 SYRINGE (68135-058-89)
Marketing
Marketing Status
Brand
palynziq
Generic
pegvaliase-pqpz
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["SUBCUTANEOUS"], "spl_id": "b7b7caec-2808-4d88-ae34-1129a2cb1aef", "openfda": {"nui": ["N0000193858", "M0016545"], "unii": ["N6UAH27EUV"], "rxcui": ["2046365", "2046370", "2046374", "2046376", "2046379", "2046380"], "spl_set_id": ["6dba844a-db02-44f8-8593-ce497ed9406c"], "pharm_class_cs": ["Phenylalanine Ammonia-Lyase [CS]"], "pharm_class_epc": ["Phenylalanine Metabolizing Enzyme [EPC]"], "manufacturer_name": ["BioMarin Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (68135-058-90) / .5 mL in 1 SYRINGE (68135-058-89)", "package_ndc": "68135-058-90", "marketing_start_date": "20180524"}], "brand_name": "Palynziq", "product_id": "68135-058_b7b7caec-2808-4d88-ae34-1129a2cb1aef", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phenylalanine Ammonia-Lyase [CS]", "Phenylalanine Metabolizing Enzyme [EPC]"], "product_ndc": "68135-058", "generic_name": "pegvaliase-pqpz", "labeler_name": "BioMarin Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Palynziq", "active_ingredients": [{"name": "PEGVALIASE", "strength": "2.5 mg/.5mL"}], "application_number": "BLA761079", "marketing_category": "BLA", "marketing_start_date": "20180524", "listing_expiration_date": "20271231"}