FDA.reportPublic FDA data

Tygacil

Product NDC
0008-4994
11-digit product format
000084994
Labeler code
0008
Product ID
0008-4994_632c318a-2046-484c-9b5d-af354cbca86a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIGECYCLINE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application
NDA021821
Marketing category
NDA
Marketing start
2017-02-08
Substance
TIGECYCLINE
Active strength
50 mg/5mL
Pharmacologic classes
Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tygacil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIGECYCLINE50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii70JE2N95KR
Rxcui581531, 584201

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dd6d14ea-96ce-47d6-bb4d-e83a98d059a0Product name120181011
ce7f9e4b-57d2-4e93-9935-2aafa036a504Product name120180424
ae8ca335-9ee1-4a78-92e9-2334f46963a8Product name120170214
72b449d8-80ee-4105-8917-897614a9b02bProduct name120150611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0008-4994-19Tygacil5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,515
0008-4994-20Tygacil10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0008-4994-19EA - Each0008-499490e2543d-fc68-401a-b5a2-1825e1d554d812017-03-06
0008-4994-20EA - Each0008-4994b9b00f4c-a988-4480-9104-83bb29fc2b1912017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0008-4994TYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]13Current NDC, Legacy NDC, 2 package rows20250507_fd826e47-1b77-4ffd-bb22-fda3379903b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581531tigecycline 50 MG InjectionPSNfd826e47-1b77-4ffd-bb22-fda3379903b015
584201Tygacil 50 MG InjectionPSNfd826e47-1b77-4ffd-bb22-fda3379903b015
584201tigecycline 50 MG Injection [Tygacil]SBDfd826e47-1b77-4ffd-bb22-fda3379903b015
581531tigecycline 50 MG InjectionSCDfd826e47-1b77-4ffd-bb22-fda3379903b015
584201Tygacil 50 MG InjectionSYfd826e47-1b77-4ffd-bb22-fda3379903b015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0008-4994-19000084994195 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
0008-4994-200000849942010 VIAL, SINGLE-DOSE in 1 CARTON (0008-4994-20) / 5 mL in 1 VIAL, SINGLE-DOSE (0008-4994-19) 2017-02-080000-00-00NoNoCurrent