FDA.reportPublic FDA data

NDC 71288-019-91 - 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
71288-019
Requested NDC
71288-019-91
Package NDCs from labels
71288-019-91, 71288-019-92, 71288-019-10, 71288-019-11
Manufacturer
Meitheal Pharmaceuticals Inc.
Effective date
2026-02-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tigecycline - Meitheal Pharmaceuticals Inc.Meitheal Pharmaceuticals Inc.2026-02-17HUMAN PRESCRIPTION DRUG LABEL
Tigecycline - Meitheal Pharmaceuticals Inc.Meitheal Pharmaceuticals Inc.2025-09-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-019-10Tigecycline5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,55
71288-019-11Tigecycline10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,105
71288-019-91Tigecycline5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,51
71288-019-92Tigecycline10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-019TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20210520_4cbefeb0-7d63-4c49-9906-384acc53dd15.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-019-10EA - Each71288-019913c3674-01be-4829-a6bc-e6a8a76bd42a12022-11-07
71288-019-11EA - Each71288-019c77349ae-cf7f-4dee-b993-6c755987caac12022-11-07

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
application number: ANDA214020
ndc (package): 71288-019-91
ndc (package): 71288-019-92
ndc (product): 71288-019
ndc11 (package): 71288001991
rxcui: 581531
spl id: c2fe6458-6520-40dd-abf2-7772755e79af
spl set id: 6e9a34af-8dee-4ba2-9157-2f5cb46958a9
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
application number: ANDA214020
ndc (package): 71288-019-10
ndc (package): 71288-019-11
ndc (product): 71288-019
rxcui: 581531
spl id: 944a7489-75b7-4841-a189-1bb66fa83e30
spl set id: 4cbefeb0-7d63-4c49-9906-384acc53dd15
unii: 70JE2N95KR
TigecyclineTIGECYCLINESandoz Inc50605463-2dc2-4b27-bc51-4d87bb9a85392025-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 581531
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.