Package 63323-421-02
Brand: dexmedetomidine hydrochloride
Generic: dexmedetomidine hydrochloridePackage Facts
Identity
Package NDC
63323-421-02
Digits Only
6332342102
Product NDC
63323-421
Description
25 VIAL in 1 TRAY (63323-421-02) / 2 mL in 1 VIAL (63323-421-01)
Marketing
Marketing Status
Brand
dexmedetomidine hydrochloride
Generic
dexmedetomidine hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "56e0af34-aeb5-4b37-8c61-2e90b2c8ca6c", "openfda": {"upc": ["0363323421014"], "unii": ["1018WH7F9I"], "rxcui": ["309710"], "spl_set_id": ["c1b8eb58-596b-481d-beb6-ba9d2237abf4"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (63323-421-02) / 2 mL in 1 VIAL (63323-421-01)", "package_ndc": "63323-421-02", "marketing_start_date": "20150918"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "63323-421_56e0af34-aeb5-4b37-8c61-2e90b2c8ca6c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "63323-421", "generic_name": "dexmedetomidine hydrochloride", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine Hydrochloride", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA201072", "marketing_category": "ANDA", "marketing_start_date": "20150918", "listing_expiration_date": "20261231"}