Tigecycline

Product NDC
55150-228
11-digit product format
551500228
Labeler code
55150
Product ID
55150-228_a5262444-a326-478c-a6d6-b515ef3d1219
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tigecycline
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA206335
Marketing category
ANDA
Marketing start
2019-06-11
Substance
TIGECYCLINE
Active strength
50 mg/1
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
Tigecycline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIGECYCLINE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii70JE2N95KR
Rxcui581531

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
55150-228-10Tigecycline1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,18
55150-228-10Tigecycline10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-228-10EA - Each55150-22884ab9e76-70a5-44a7-aa83-f63bb419889b12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-228TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]8Current NDC, Legacy NDC, 2 package rows20250430_dd58e0c3-d8a8-4cf2-96f8-9dd08f309579.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581531tigecycline 50 MG InjectionPSNdd58e0c3-d8a8-4cf2-96f8-9dd08f3095798
581531tigecycline 50 MG InjectionSCDdd58e0c3-d8a8-4cf2-96f8-9dd08f3095798

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-228-105515002281010 VIAL, SINGLE-DOSE in 1 CARTON (55150-228-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2019-06-110000-00-00NoNoCurrent