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United States · US · US:0008-4990_471458bc-2d5f-470b-a6a4-f4bf0eacf95b
Tygacil
Orange BookUNIISPLATC J01AA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
CountryUS (United States)
ATC codeJ01AA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11000849902010 VIAL, SINGLE-DOSE in 1 CARTON (0008-4990-20) / 5 mL in 1 VIAL, SINGLE-DOSE (0008-4990-19)
Annotations
UNII (FDA Substance ID)
70JE2N95KR
TIGECYCLINE
RxCUI 384455
Orange Book
N021821
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",
"spl_meta": {
"fd826e47-1b77-4ffd-bb22-fda3379903b0": {
"match": "brand_token",
"title": "TYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]",
"spl_version": "15",
"published_date": "2025-11-19"
}
},
"productid": "0008-4990_471458bc-2d5f-470b-a6a4-f4bf0eacf95b",
"productndc": "0008-4990",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "021821",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "50MG/VIAL",
"product_no": "001",
"approval_date": "Jun 15, 2005"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIGECYCLINE",
"proprietary_name": "Tygacil",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA021821",
"marketing_category": "NDA",
"nonproprietary_name": "TIGECYCLINE",
"start_marketing_date": "20080615",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J01AA12.
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- 🇪🇸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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