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United States · US · US:70842-140_4c7649f3-4d38-47e2-aa0d-2ed606bb930a
Orbactiv
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
- ndc1170842140033 VIAL, GLASS in 1 CARTON (70842-140-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01)
Annotations
UNII (FDA Substance ID)
PUG62FRZ2E
ORITAVANCIN
RxCUI 1547611
Orange Book
N206334
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "PUG62FRZ2E",
"rxcui": "1547611",
"inchikey": "VHFGEBVPHAGQPI-LXKZPTCJSA-N",
"display_name": "ORITAVANCIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"ff09a726-9f9b-4e30-b509-396781293220": {
"match": "brand_token",
"title": "ORBACTIV (ORITAVANCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC]",
"spl_version": "12",
"published_date": "2025-07-23"
}
},
"productid": "70842-140_4c7649f3-4d38-47e2-aa0d-2ed606bb930a",
"productndc": "70842-140",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "206334",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 400MG BASE/VIAL",
"product_no": "001",
"approval_date": "Aug 6, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ORITAVANCIN",
"proprietary_name": "Orbactiv",
"active_ingred_unit": "mg/1",
"application_number": "NDA206334",
"marketing_category": "NDA",
"nonproprietary_name": "oritavancin",
"start_marketing_date": "20140901",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code J01XA05.
- 🇺🇸KimyrsaMelinta Therapeutics, LLC
- PLTenkasiMenarini International Operations Luxembourg S.A.
- DKTenkasiMenarini International Operation Luxembourg S.A.
- 🇨🇭TenkasiA. Menarini GmbH
- 🇨🇭TenkasiA. Menarini GmbH
- DKTenkasiMenarini International Operation Luxembourg S.A.
- PLTenkasiMenarini International Operations Luxembourg S.A.
- ISTenkasiMenarini International Operations Luxembourg S.A.
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