Package 0641-6254-01
Brand: hydromorphone hydrochloride
Generic: hydromorphone hydrochloridePackage Facts
Identity
Package NDC
0641-6254-01
Digits Only
0641625401
Product NDC
0641-6254
Description
1 VIAL in 1 CARTON (0641-6254-01) / 20 mL in 1 VIAL
Marketing
Marketing Status
Brand
hydromorphone hydrochloride
Generic
hydromorphone hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "ba25ec4f-3b81-4960-bf74-6a1e4c6be45c", "openfda": {"unii": ["L960UP2KRW"], "rxcui": ["897745"], "spl_set_id": ["c729424e-e483-4bf8-b86c-ce56636dcffa"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0641-6254-01) / 20 mL in 1 VIAL", "package_ndc": "0641-6254-01", "marketing_start_date": "20250513"}], "brand_name": "Hydromorphone Hydrochloride", "product_id": "0641-6254_ba25ec4f-3b81-4960-bf74-6a1e4c6be45c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0641-6254", "dea_schedule": "CII", "generic_name": "Hydromorphone Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydromorphone Hydrochloride", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "NDA217812", "marketing_category": "NDA", "marketing_start_date": "20250513", "listing_expiration_date": "20261231"}