Package 43598-976-58
Brand: dexmedetomidine hydrochloride
Generic: dexmedetomidine hydrochloridePackage Facts
Identity
Package NDC
43598-976-58
Digits Only
4359897658
Product NDC
43598-976
Description
10 VIAL in 1 CARTON (43598-976-58) / 50 mL in 1 VIAL (43598-976-11)
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": "5785a11f-7784-4ae0-8029-f50b782eaf4a", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["1718906", "1718909"], "spl_set_id": ["d174c19d-56f1-4ef4-087c-23c26db8e40b"], "manufacturer_name": ["Dr.Reddy's Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (43598-976-58) / 50 mL in 1 VIAL (43598-976-11)", "package_ndc": "43598-976-58", "marketing_start_date": "20200817"}], "brand_name": "DEXMEDETOMIDINE HYDROCHLORIDE", "product_id": "43598-976_5785a11f-7784-4ae0-8029-f50b782eaf4a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "43598-976", "generic_name": "DEXMEDETOMIDINE HYDROCHLORIDE", "labeler_name": "Dr.Reddy's Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXMEDETOMIDINE HYDROCHLORIDE", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "4 ug/mL"}], "application_number": "ANDA209307", "marketing_category": "ANDA", "marketing_start_date": "20200817", "listing_expiration_date": "20261231"}