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United States · US · US:70842-225_25ae2ae5-afce-4475-bf3c-45323e93a952
Kimyrsa
Orange BookUNIISPLATC J01XA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMelinta Therapeutics, LLC
CountryUS (United States)
ATC codeJ01XA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170842225011 VIAL in 1 CARTON (70842-225-01) / 40 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
VL1P93MKZN
ORITAVANCIN DIPHOSPHATE
RxCUI 1549827
Orange Book
N214155
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "VL1P93MKZN",
"rxcui": "1549827",
"inchikey": "PWTROOMOPLCZHB-BHYQHFGMSA-N",
"display_name": "ORITAVANCIN DIPHOSPHATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"5e755c40-6e73-4572-b474-4d8a131693d1": {
"match": "brand_token",
"title": "KIMYRSA (ORITAVANCIN DIPHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC]",
"spl_version": "7",
"published_date": "2025-12-22"
}
},
"productid": "70842-225_25ae2ae5-afce-4475-bf3c-45323e93a952",
"productndc": "70842-225",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "214155",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1.2GM BASE/VIAL",
"product_no": "001",
"approval_date": "Mar 12, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ORITAVANCIN DIPHOSPHATE",
"proprietary_name": "Kimyrsa",
"active_ingred_unit": "mg/40mL",
"application_number": "NDA214155",
"marketing_category": "NDA",
"nonproprietary_name": "oritavancin diphosphate",
"start_marketing_date": "20210323",
"active_numerator_strength": "1200"
}Related drugs
Other records sharing ATC code J01XA05.
- 🇺🇸OrbactivMelinta Therapeutics, LLC
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- DKTenkasiMenarini International Operation Luxembourg S.A.
- PLTenkasiMenarini International Operations Luxembourg S.A.
- 🇨🇭TenkasiA. Menarini GmbH
- 🇨🇭TenkasiA. Menarini GmbH
- ISTenkasiMenarini International Operations Luxembourg S.A.
- ISTenkasiMenarini International Operations Luxembourg S.A.
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