FDA.reportPublic FDA data

NDC 0008-4990-02 - Tygacil

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
0008-4990
Requested NDC
0008-4990-02
Package NDCs from labels
0008-4990-19, 0008-4990-20, 0008-4990-02
Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Patheon Italia S.p.A | Pharmacia & Upjohn Company LLC | Wyeth Lederle SRL | Pfizer Ireland Pharmaceuticals Unlimited Company
Effective date
2025-11-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TygacilWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Patheon Italia S.p.A | Pharmacia & Upjohn Company LLC | Wyeth Lederle SRL | Pfizer Ireland Pharmaceuticals Unlimited Company2025-11-18HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0008-4990-19Tygacil5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,550
0008-4990-20Tygacil10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1050

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0008-4990TYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]48Current NDC, Legacy NDC, 2 package rows20250501_2ccdb48e-c14a-4eeb-348c-4920ccfd7465.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0008-4990-01EA - Each0008-49905394e4a0-2a43-4ad6-a563-e7561e2efaa112016-07-19
0008-4990-02EA - Each0008-4990e4ce5f4e-60ed-41f5-acd4-d5ee796fedd212012-07-24
0008-4990-19EA - Each0008-49909a8e5299-e865-428c-8265-5e0ff19b2f6a12012-07-24
0008-4990-20EA - Each0008-49903ae022f3-6c4a-4b46-b176-d2403349d56412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIGECYCLINEACTIVE INGREDIENT70JE2N95KRTYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]29
TIGECYCLINEACTIVE MOIETY70JE2N95KRTYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]29
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBTYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]29
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]29
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]29

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
application number: NDA021821
ndc (package): 0008-4990-19
ndc (package): 0008-4990-20
ndc (product): 0008-4990
rxcui: 584201
rxcui: 581531
spl id: 471458bc-2d5f-470b-a6a4-f4bf0eacf95b
spl set id: 2ccdb48e-c14a-4eeb-348c-4920ccfd7465
unii: 70JE2N95KR
TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.fd826e47-1b77-4ffd-bb22-fda3379903b02025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021821
rxcui: 584201
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
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.