🇺🇸
United States · US · US:0781-3481_7eeef6bf-1bb2-42d7-9ee2-1a3865b9b11c
Tigecycline
Orange BookUNIISPLATC J01AA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeJ01AA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11078134819210 VIAL, SINGLE-DOSE in 1 CARTON (0781-3481-92) / 10 mL in 1 VIAL, SINGLE-DOSE (0781-3481-70)
Annotations
UNII (FDA Substance ID)
70JE2N95KR
TIGECYCLINE
RxCUI 384455
Orange Book
A091620
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "70JE2N95KR",
"rxcui": "384455",
"inchikey": "FPZLLRFZJZRHSY-HJYUBDRYSA-N",
"display_name": "TIGECYCLINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS; PARENTERAL",
"spl_meta": {
"6e9a34af-8dee-4ba2-9157-2f5cb46958a9": {
"match": "brand_token",
"title": "TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]",
"spl_version": "1",
"published_date": "2026-04-02"
}
},
"productid": "0781-3481_7eeef6bf-1bb2-42d7-9ee2-1a3865b9b11c",
"productndc": "0781-3481",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "091620",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/VIAL",
"product_no": "001",
"approval_date": "May 27, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIGECYCLINE",
"proprietary_name": "Tigecycline",
"active_ingred_unit": "mg/10mL",
"application_number": "ANDA091620",
"marketing_category": "ANDA",
"nonproprietary_name": "Tigecycline",
"start_marketing_date": "20171130",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J01AA12.
- 🇪🇸TIGECICLINA ACCORD 50 MG POLVO PARA SOLUCION PARA PERFUSION EFGAccord Healthcare S.L.U.
- 🇪🇸TIGECICLINA CIPLA 50 MG POLVO PARA SOLUCION PARA PERFUSION EFGCipla Europe N.V.
- 🇪🇸TIGECICLINA FRESENIUS KABI 50 MG POLVO PARA SOLUCION PARA PERFUSION EFGFresenius Kabi España, S.A.U.
- 🇪🇸TIGECICLINA HIKMA 50 MG POLVO PARA SOLUCION PARA PERFUSION EFGHikma Farmaceutica (Portugal) S.A.
- 🇪🇸TIGECICLINA NORIDEM 50 MG POLVO PARA SOLUCION PARA PERFUSION EFGNoridem Enterprises Limited
- 🇪🇸TIGECICLINA NORMON 50 MG POLVO PARA SOLUCION PARA PERFUSION EFGLaboratorios Normon S.A.
- 🇪🇸TIGECICLINA TARBIS 50 MG POLVO PARA SOLUCION PARA PERFUSION EFGTarbis Farma S.L.
- 🇪🇸TIGECICLINA TECNIGEN 50 MG POLVO PARA SOLUCION PARA PERFUSION EFGTecnimede España Industria Farmaceutica S.A.
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