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United States · US · US:70792-102_aadca804-560a-4262-843d-2cb4e2fbe851
TONMYA
Orange BookUNIISPLATC M03BX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTonix Medicines, Inc.
CountryUS (United States)
ATC codeM03BX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11707921021414 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-14)
- ndc11707921023030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-30)
- ndc11707921026060 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-60)
- ndc11707921029090 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-90)
Annotations
UNII (FDA Substance ID)
0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE
RxCUI 52101
Orange Book
N219428
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0VE05JYS2P",
"rxcui": "52101",
"inchikey": "VXEAYBOGHINOKW-UHFFFAOYSA-N",
"display_name": "CYCLOBENZAPRINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBLINGUAL",
"spl_meta": {
"6fa59588-ce9b-48cf-8c5f-725a448f8571": {
"match": "brand_token",
"title": "TONMYA (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [TONIX MEDICINES, INC.]",
"spl_version": "3",
"published_date": "2025-11-17"
}
},
"productid": "70792-102_aadca804-560a-4262-843d-2cb4e2fbe851",
"productndc": "70792-102",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "219428",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2.8MG",
"product_no": "001",
"approval_date": "Aug 15, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYCLOBENZAPRINE HYDROCHLORIDE",
"proprietary_name": "TONMYA",
"active_ingred_unit": "mg/1",
"application_number": "NDA219428",
"marketing_category": "NDA",
"nonproprietary_name": "Cyclobenzaprine Hydrochloride",
"start_marketing_date": "20250815",
"active_numerator_strength": "2.8"
}Related drugs
Other records sharing ATC code M03BX08.
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