FDA.reportPublic FDA data

Spravato

Product NDC
50458-028
11-digit product format
504580028
Labeler code
50458
Product ID
50458-028_edb747c7-957a-47fa-b5b2-51a25b31c083
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esketamine Hydrochloride
Dosage form
SOLUTION
Route
NASAL
Labeler
Janssen Pharmaceuticals Inc.
Application
NDA211243
Marketing category
NDA
Marketing start
2019-03-05
Substance
ESKETAMINE HYDROCHLORIDE
Active strength
28 mg/.2mL
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Spravato
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESKETAMINE HYDROCHLORIDE28 mg/.2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL8P1H35P2Z
Rxcui2119381, 2119387, 2119388, 2119389, 2119390, 2119391

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
78f6246b-a57c-4cd9-98c2-73b0767a033fProduct name120190618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50458-028-00Spravato0.2 mL in 1 VIAL, SINGLE-USESOLUTION0.218
50458-028-02Spravato1 in 1 BLISTER PACKSOLUTION118
50458-028-02Spravato2 in 1 KITSOLUTION218
50458-028-03Spravato3 in 1 KITSOLUTION318
50458-028-03Spravato1 in 1 BLISTER PACKSOLUTION118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-028-00EA - Each50458-028bebd456d-478d-4351-948f-e287dd1e023b12019-04-11
50458-028-02EA - Each50458-028c31f11b0-2ebd-4f8d-b134-b1b7b91c3b3b12019-04-11
50458-028-03EA - Each50458-02868e59244-29fd-4679-8d6b-b43daaf897d812019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-028SPRAVATO (ESKETAMINE HYDROCHLORIDE) SOLUTION [JANSSEN PHARMACEUTICALS INC.]16Current NDC, Legacy NDC, 5 package rows20250514_d81a6a79-a74a-44b7-822c-0dfa3036eaed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2119391{2 (0.2 ML) (esketamine 140 MG/ML Nasal Spray [Spravato]) } Pack [Spravato 56 MG Dose Kit]BPCKd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119389{3 (0.2 ML) (esketamine 140 MG/ML Nasal Spray [Spravato]) } Pack [Spravato 84 MG Dose Kit]BPCKd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119390{2 (0.2 ML) (esketamine 140 MG/ML Nasal Spray) } PackGPCKd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119388{3 (0.2 ML) (esketamine 140 MG/ML Nasal Spray) } PackGPCKd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119381esketamine 140 MG/mL Nasal SprayPSNd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119390esketamine HCl 56 MG (28 MG x 2) Nasal SprayPSNd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119388esketamine HCl 84 MG (28 MG x 3) Nasal SprayPSNd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119387Spravato 28 MG in 0.2 mL Nasal SprayPSNd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119391Spravato 56 MG Dose KitPSNd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119389Spravato 84 MG Dose KitPSNd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119387esketamine 140 MG/ML Nasal Spray [Spravato]SBDd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119381esketamine 140 MG/ML Nasal SpraySCDd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119390esketamine 140 MG/mL Metered Dose Nasal Spray (2- 0.2 OZ Pack)SYd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119388esketamine 140 MG/mL Nasal Spray (3- 0.2 OZ Pack)SYd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119387Spravato 140 MG/ML Nasal SpraySYd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119387Spravato 28 MG per 0.2 ML Nasal SpraySYd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119391Spravato 56 MG Dose KitSYd81a6a79-a74a-44b7-822c-0dfa3036eaed18
2119389Spravato 84 MG Dose KitSYd81a6a79-a74a-44b7-822c-0dfa3036eaed18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50458-028-00504580028000.2 mL in 1 VIAL, SINGLE-USE0.2 mlHistorical
50458-028-02504580028022 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) 2 blister pack2019-03-050000-00-00NoNoCurrent
50458-028-03504580028033 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) 3 blister pack2019-03-050000-00-00NoNoCurrent