spravato

Generic: esketamine hydrochloride

Labeler: janssen pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name spravato
Generic Name esketamine hydrochloride
Labeler janssen pharmaceuticals inc.
Dosage Form SOLUTION
Routes
NASAL
Active Ingredients

esketamine hydrochloride 28 mg/.2mL

Manufacturer
Janssen Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50458-028
Product ID 50458-028_3d47667a-c137-4421-e063-6294a90a35f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211243
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2019-03-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458028
Hyphenated Format 50458-028

Supplemental Identifiers

RxCUI
2119381 2119387 2119388 2119389 2119390 2119391
UNII
L8P1H35P2Z

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name spravato (source: ndc)
Generic Name esketamine hydrochloride (source: ndc)
Application Number NDA211243 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 28 mg/.2mL
source: ndc
Packaging
  • 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)
  • 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)
source: ndc

Packages (2)

50458-028-02 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) 50458-028-03 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)

Ingredients (1)

esketamine hydrochloride (28 mg/.2mL)

Linked Drug Pages (1)

Spravato ndc-match (0.9)

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"}