FDA.reportPublic FDA data

NDC 0781-3481-70 - Tigecycline

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0781-3481
Requested NDC
0781-3481-70
Package NDCs from labels
0781-3481-70, 0781-3481-92
Manufacturer
Sandoz Inc
Effective date
2025-08-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tigecycline - Sandoz IncSandoz Inc2025-08-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3481-70Tigecycline10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1020
0781-3481-92Tigecycline10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3481TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]19Current NDC, Legacy NDC, 2 package rows20210810_50605463-2dc2-4b27-bc51-4d87bb9a8539.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3481-70EA - Each0781-34813dcb745b-c7ce-4e61-9185-e8272219ec4b12021-09-07
0781-3481-92EA - Each0781-3481ed4b026b-0a17-45b4-9e4a-da5a06d1e99c12018-01-12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
TigecyclineTIGECYCLINEMeitheal Pharmaceuticals Inc.6e9a34af-8dee-4ba2-9157-2f5cb46958a92026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 581531
unii: 70JE2N95KR
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
TigecyclineTIGECYCLINEApotex Corp230484a8-408c-dcc1-d0c4-d9dd9a46831b2026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 581531
unii: 70JE2N95KR
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB
TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.2ccdb48e-c14a-4eeb-348c-4920ccfd74652025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 581531
unii: 70JE2N95KR
TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.fd826e47-1b77-4ffd-bb22-fda3379903b02025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 581531
unii: 70JE2N95KR
TigecyclineTIGECYCLINEMeitheal Pharmaceuticals Inc.4cbefeb0-7d63-4c49-9906-384acc53dd152025-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 581531
unii: 70JE2N95KR
TigecyclineTIGECYCLINESandoz Inc50605463-2dc2-4b27-bc51-4d87bb9a85392025-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091620
ndc (package): 0781-3481-70
ndc (package): 0781-3481-92
ndc (product): 0781-3481
ndc11 (package): 00781348170
rxcui: 581531
spl id: c5721224-91db-4fe4-b746-139bce5ff19c
spl set id: 50605463-2dc2-4b27-bc51-4d87bb9a8539
unii: 70JE2N95KR
TigecyclineTIGECYCLINEEugia US LLCdd58e0c3-d8a8-4cf2-96f8-9dd08f3095792025-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 581531
unii: 70JE2N95KR
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB
Bestmade Natural Products BM62AMMONIUM BENZOICUM, AURUM MUR, CALC ARS, CARDUUS MAR, CROTALUS HORRIDUS, MURIATIC ACID, NUX VOM, PHOSPHORUS, VIPERABestmade Natural Products2ce99cb7-fe9e-5da2-e063-6294a90afc4e2025-01-30WarningsExact identifier
unii: QTT17582CB
D-114ALUMINUM METALLICUM, AILANTHUS, BAPTISIA TINCTORIA, FRAGARIA VESCA, YOSCYAMUS NIGER, MURIATICUM ACIDDNA Labsf6f7d369-64ef-0ed9-e053-6294a90a40fa2025-01-13WarningsExact identifier
unii: QTT17582CB
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUMSilver Star Brands05e04129-e7c1-4e11-e063-6394a90a09ca2025-01-01WarningsExact identifier
unii: QTT17582CB
TigecyclineTIGECYCLINEAmneal Pharmaceuticals LLC8450bd15-2b06-4fc7-b302-9021312e3f0d2024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 581531
unii: 70JE2N95KR
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.