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United States · US · US:72252-520_a170c6ff-67a0-46be-a207-8fd758c7d103
Valtoco
Orange BookUNIISPLATC N05BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNeurelis, Inc
CountryUS (United States)
ATC codeN05BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1172252520042 BLISTER PACK in 1 CARTON (72252-520-04) / 2 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE
- ndc1172252520102 BLISTER PACK in 1 CARTON (72252-520-10) / 2 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
Q3JTX2Q7TU
DIAZEPAM
RxCUI 3322
Orange Book
N211635
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Q3JTX2Q7TU",
"rxcui": "3322",
"inchikey": "AAOVKJBEBIDNHE-UHFFFAOYSA-N",
"display_name": "DIAZEPAM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "NASAL",
"spl_meta": {
"1a8bcc90-68fa-474d-832c-0df01e825f39": {
"match": "brand_token",
"title": "VALTOCO (DIAZEPAM) SPRAY [NEURELIS, INC]",
"spl_version": "14",
"published_date": "2026-03-23"
}
},
"productid": "72252-520_a170c6ff-67a0-46be-a207-8fd758c7d103",
"productndc": "72252-520",
"dosage_form": "SPRAY",
"orange_book": {
"appl_no": "211635",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG/SPRAY",
"product_no": "001",
"approval_date": "Jan 10, 2020"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "7.5MG/SPRAY",
"product_no": "002",
"approval_date": "Jan 10, 2020"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG/SPRAY",
"product_no": "003",
"approval_date": "Jan 10, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIAZEPAM",
"proprietary_name": "Valtoco",
"active_ingred_unit": "mg/.1mL",
"application_number": "NDA211635",
"marketing_category": "NDA",
"nonproprietary_name": "diazepam",
"start_marketing_date": "20200110",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05BA01.
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