FDA.reportPublic FDA data

Tigecycline

Product NDC
0781-3481
11-digit product format
007813481
Labeler code
0781
Product ID
0781-3481_7eeef6bf-1bb2-42d7-9ee2-1a3865b9b11c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tigecycline
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; PARENTERAL
Labeler
Sandoz Inc
Application
ANDA091620
Marketing category
ANDA
Marketing start
2017-11-30
Substance
TIGECYCLINE
Active strength
50 mg/10mL
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/10mL

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
0781-3481-70Tigecycline10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1020
0781-3481-92Tigecycline10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1020

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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581531tigecycline 50 MG InjectionPSN50605463-2dc2-4b27-bc51-4d87bb9a853920
581531tigecycline 50 MG InjectionSCD50605463-2dc2-4b27-bc51-4d87bb9a853920

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3481-700078134817010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
0781-3481-920078134819210 VIAL, SINGLE-DOSE in 1 CARTON (0781-3481-92) / 10 mL in 1 VIAL, SINGLE-DOSE (0781-3481-70) 2017-11-300000-00-00NoNoCurrent