Package 63323-671-00
Brand: dexmedetomidine hydrochloride
Generic: dexmedetomidine hydrochloridePackage Facts
Identity
Package NDC
63323-671-00
Digits Only
6332367100
Product NDC
63323-671
Description
10 BOTTLE, GLASS in 1 CARTON (63323-671-00) / 100 mL in 1 BOTTLE, GLASS (63323-671-01)
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": "27411591-44a1-44c4-89c3-dd8c2687f0e2", "openfda": {"upc": ["0363323671020", "0363323671051"], "unii": ["1018WH7F9I"], "rxcui": ["1718900", "1718906", "1718909"], "spl_set_id": ["4d5d2294-89a0-4b6f-aa00-d39a0393b6a8"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE, GLASS in 1 CARTON (63323-671-00) / 100 mL in 1 BOTTLE, GLASS (63323-671-01)", "package_ndc": "63323-671-00", "marketing_start_date": "20190513"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-671-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-671-02)", "package_ndc": "63323-671-20", "marketing_start_date": "20190513"}, {"sample": false, "description": "25 BOTTLE, GLASS in 1 CARTON (63323-671-50) / 50 mL in 1 BOTTLE, GLASS (63323-671-05)", "package_ndc": "63323-671-50", "marketing_start_date": "20190513"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "63323-671_27411591-44a1-44c4-89c3-dd8c2687f0e2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "63323-671", "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": "4 ug/mL"}], "application_number": "ANDA208129", "marketing_category": "ANDA", "marketing_start_date": "20190513", "listing_expiration_date": "20261231"}