FDA.reportPublic FDA data

Valtoco

Product NDC
72252-520
11-digit product format
722520520
Labeler code
72252
Product ID
72252-520_a170c6ff-67a0-46be-a207-8fd758c7d103
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
SPRAY
Route
NASAL
Labeler
Neurelis, Inc
Application
NDA211635
Marketing category
NDA
Marketing start
2020-01-10
Substance
DIAZEPAM
Active strength
10 mg/.1mL
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM10 mg/.1mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui2272613, 2272619, 2272621, 2272622, 2272623, 2272624, 2272626, 2272627, 2272629, 2272630, 2272632, 2272633, 2272635, 2272636

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
69057c52-36b0-21c0-02d6-d697be15c03cProduct name420260305
da74e203-d183-4c62-8511-c3ef56b5964eProduct name120250213
2792dd44-ff30-4712-8b05-1850c2b4d307Product name320250211
2fd3ebb9-86c1-64e3-e9b6-3c2ba01c6876Product name220250102
0f898f8b-23f1-b816-6bfe-c7f8aac7e42bProduct name220240529
2c487d7e-cbfc-4699-9c83-5c1c7521cde9Product name120200610
02ac201d-7ee6-00c9-f963-81bb5a506b68Product name320160816

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72252-520-042023-08-17C16284748780-10191ceaa-6d38-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use VALTOCO nasal spray safely and effectively. See full prescribing information for VALTOCO nasal spray. VALTOCO ® (diazepam nasal spray), CIV Initial U.S. Approval: 1963
72252-520-042023-07-28C16284748780-10191ceaa-6d38-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use VALTOCO nasal spray safely and effectively. See full prescribing information for VALTOCO nasal spray. VALTOCO ® (diazepam nasal spray), CIV Initial U.S. Approval: 1963

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72252-520-04Valtoco2 in 1 CARTONSPRAY214
72252-520-04Valtoco2 in 1 BLISTER PACKSPRAY214
72252-520-10Valtoco2 in 1 BLISTER PACKSPRAY214
72252-520-10Valtoco2 in 1 CARTONSPRAY214

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72252-520VALTOCO (DIAZEPAM) SPRAY [NEURELIS, INC]11Current NDC, Legacy NDC, 4 package rows20250508_1a8bcc90-68fa-474d-832c-0df01e825f39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2272622{1 (0.1 ML) (diazepam 100 MG/ML Nasal Spray [Valtoco]) } Pack [Valtoco 10 MG Dose Kit]BPCK1a8bcc90-68fa-474d-832c-0df01e825f3914
2272630{1 (0.1 ML) (diazepam 50 MG/ML Nasal Spray [Valtoco]) } Pack [Valtoco 5 MG Dose Kit]BPCK1a8bcc90-68fa-474d-832c-0df01e825f3914
2272624{2 (0.1 ML) (diazepam 100 MG/ML Nasal Spray [Valtoco]) } Pack [Valtoco 20 MG Dose Kit]BPCK1a8bcc90-68fa-474d-832c-0df01e825f3914
2272636{2 (0.1 ML) (diazepam 75 MG/ML Nasal Spray [Valtoco]) } Pack [Valtoco 15 MG Dose Kit]BPCK1a8bcc90-68fa-474d-832c-0df01e825f3914
2272621{1 (0.1 ML) (diazepam 100 MG/ML Nasal Spray) } PackGPCK1a8bcc90-68fa-474d-832c-0df01e825f3914
2272627{1 (0.1 ML) (diazepam 50 MG/ML Nasal Spray) } PackGPCK1a8bcc90-68fa-474d-832c-0df01e825f3914
2272623{2 (0.1 ML) (diazepam 100 MG/ML Nasal Spray) } PackGPCK1a8bcc90-68fa-474d-832c-0df01e825f3914
2272633{2 (0.1 ML) (diazepam 75 MG/ML Nasal Spray) } PackGPCK1a8bcc90-68fa-474d-832c-0df01e825f3914
2272613diazePAM 10 MG in 0.1 mL Nasal SprayPSN1a8bcc90-68fa-474d-832c-0df01e825f3914
2272621diazePAM 10 MG in 0.1 mL Nasal Spray Dose KitPSN1a8bcc90-68fa-474d-832c-0df01e825f3914
2272633diazePAM 15 MG (2 X 7.5 MG in 0.1 mL) Nasal Spray Dose KitPSN1a8bcc90-68fa-474d-832c-0df01e825f3914
2272623diazePAM 20 MG (2 X 10 MG in 0.1 mL) Nasal Spray Dose KitPSN1a8bcc90-68fa-474d-832c-0df01e825f3914
2272626diazePAM 5 MG in 0.1 mL Nasal SprayPSN1a8bcc90-68fa-474d-832c-0df01e825f3914
2272627diazePAM 5 MG in 0.1 mL Nasal Spray Dose KitPSN1a8bcc90-68fa-474d-832c-0df01e825f3914
2272632diazePAM 7.5 MG in 0.1 mL Nasal SprayPSN1a8bcc90-68fa-474d-832c-0df01e825f3914
2272622VALTOCO 10 MG Dose KitPSN1a8bcc90-68fa-474d-832c-0df01e825f3914
2272619VALTOCO 10 MG in 0.1 mL Nasal SprayPSN1a8bcc90-68fa-474d-832c-0df01e825f3914
2272636VALTOCO 15 MG Dose KitPSN1a8bcc90-68fa-474d-832c-0df01e825f3914
2272624VALTOCO 20 MG Dose KitPSN1a8bcc90-68fa-474d-832c-0df01e825f3914
2272630VALTOCO 5 MG Dose KitPSN1a8bcc90-68fa-474d-832c-0df01e825f3914
2272629Valtoco 5 MG per 0.1 mL Nasal SprayPSN1a8bcc90-68fa-474d-832c-0df01e825f3914
2272635Valtoco 7.5 MG in 0.1 mL Nasal SprayPSN1a8bcc90-68fa-474d-832c-0df01e825f3914
2272619diazepam 100 MG/ML Nasal Spray [Valtoco]SBD1a8bcc90-68fa-474d-832c-0df01e825f3914
2272629diazepam 50 MG/ML Nasal Spray [Valtoco]SBD1a8bcc90-68fa-474d-832c-0df01e825f3914
2272635diazepam 75 MG/ML Nasal Spray [Valtoco]SBD1a8bcc90-68fa-474d-832c-0df01e825f3914
2272613diazepam 100 MG/ML Nasal SpraySCD1a8bcc90-68fa-474d-832c-0df01e825f3914
2272626diazepam 50 MG/ML Nasal SpraySCD1a8bcc90-68fa-474d-832c-0df01e825f3914
2272632diazepam 75 MG/ML Nasal SpraySCD1a8bcc90-68fa-474d-832c-0df01e825f3914
2272613diazepam 10 MG per 0.1 mL Nasal SpraySY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272621diazepam 10 MG per 0.1 mL Nasal Spray Dose KitSY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272633diazepam 15 MG (2 X 7.5 MG per 0.1 mL) Nasal Spray Dose KitSY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272623diazepam 20 MG (2 X 10 MG per 0.1 mL) Nasal Spray Dose KitSY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272626diazepam 5 MG in 0.1 mL Nasal SpraySY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272627diazepam 5 MG per 0.1 mL Nasal Spray Dose KitSY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272632diazepam 7.5 MG per 0.1 mL Nasal SpraySY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272622VALTOCO 10 MG Dose KitSY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272619Valtoco 10 MG per 0.1 mL Nasal SpraySY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272619Valtoco 100 MG/ML Nasal SpraySY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272636VALTOCO 15 MG Dose KitSY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272624VALTOCO 20 MG Dose KitSY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272630VALTOCO 5 MG Dose KitSY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272629Valtoco 5 MG per 0.1 ML Nasal SpraySY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272629Valtoco 50 MG/ML Nasal SpraySY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272635Valtoco 7.5 MG per 0.1 ML Nasal SpraySY1a8bcc90-68fa-474d-832c-0df01e825f3914
2272635Valtoco 75 MG/ML Nasal SpraySY1a8bcc90-68fa-474d-832c-0df01e825f3914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72252-520-04722520520042 BLISTER PACK in 1 CARTON (72252-520-04) / 2 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE2 blister pack2020-01-100000-00-00NoNoCurrent
72252-520-10722520520102 BLISTER PACK in 1 CARTON (72252-520-10) / 2 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE2 blister pack2025-02-28NoNoCurrent