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NDC 50458-0028-02 Spravato 28 mg/.2mL Details
Spravato 28 mg/.2mL
Spravato is a NASAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Pharmaceuticals Inc.. The primary component is ESKETAMINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Esketamine nasal spray is used along with another antidepressant, taken by mouth, to manage treatment-resistant depression (TRD; depression that does not improve with treatment) in adults. It is also used along with another antidepressant, taken by mouth, to treat depressive symptoms in adults with major depressive disorder (MDD) and suicidal thoughts or actions. Esketamine is in a class of medications called NMDA receptor antagonists. It works by changing the activity of certain natural substances in the brain.
Related Packages: 50458-0028-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Esketamine Nasal Spray
Product Information
| NDC | 50458-0028 |
|---|---|
| Product ID | 50458-028_088b53cb-a931-d9a7-e063-6294a90afb43 |
| Associated GPIs | 5811002010C520 5811002010C530 |
| GCN Sequence Number | 079563 |
| GCN Sequence Number Description | esketamine HCl SPRAY 28 MG NASAL |
| HIC3 | H8Z |
| HIC3 Description | ANTIDEPRESSANT - NMDA RECEPTOR ANTAGONIST |
| GCN | 46077 |
| HICL Sequence Number | 041003 |
| HICL Sequence Number Description | ESKETAMINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Spravato |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Esketamine Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | NASAL |
| Active Ingredient Strength | 28 |
| Active Ingredient Units | mg/.2mL |
| Substance Name | ESKETAMINE HYDROCHLORIDE |
| Labeler Name | Janssen Pharmaceuticals Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | CIII |
| Marketing Category | NDA |
| Application Number | NDA211243 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50458-0028-02 (50458002802)
| NDC Package Code | 50458-028-02 |
|---|---|
| Billing NDC | 50458002802 |
| Package | 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) |
| Marketing Start Date | 2019-03-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |