Package 50458-028-03
Brand: spravato
Generic: esketamine hydrochloridePackage Facts
Identity
Package NDC
50458-028-03
Digits Only
5045802803
Product NDC
50458-028
Description
3 BLISTER PACK in 1 KIT (50458-028-03) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00)
Marketing
Marketing Status
Brand
spravato
Generic
esketamine hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["NASAL"], "spl_id": "3d47667a-c137-4421-e063-6294a90a35f1", "openfda": {"unii": ["L8P1H35P2Z"], "rxcui": ["2119381", "2119387", "2119388", "2119389", "2119390", "2119391"], "spl_set_id": ["d81a6a79-a74a-44b7-822c-0dfa3036eaed"], "manufacturer_name": ["Janssen Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 KIT (50458-028-02) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00)", "package_ndc": "50458-028-02", "marketing_start_date": "20190305"}, {"sample": false, "description": "3 BLISTER PACK in 1 KIT (50458-028-03) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00)", "package_ndc": "50458-028-03", "marketing_start_date": "20190305"}], "brand_name": "Spravato", "product_id": "50458-028_3d47667a-c137-4421-e063-6294a90a35f1", "dosage_form": "SOLUTION", "product_ndc": "50458-028", "dea_schedule": "CIII", "generic_name": "Esketamine Hydrochloride", "labeler_name": "Janssen Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spravato", "active_ingredients": [{"name": "ESKETAMINE HYDROCHLORIDE", "strength": "28 mg/.2mL"}], "application_number": "NDA211243", "marketing_category": "NDA", "marketing_start_date": "20190305", "listing_expiration_date": "20261231"}