FDA.reportPublic FDA data

Tigecycline

Product NDC
60505-6098
11-digit product format
605056098
Labeler code
60505
Product ID
60505-6098_d4e75cae-c197-e995-7903-2d41c6c1371d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIGECYCLINE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp
Application
ANDA204439
Marketing category
ANDA
Marketing start
2019-04-09
Substance
TIGECYCLINE
Active strength
50 mg/5mL
Pharmacologic classes
Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tigecycline
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIGECYCLINE50 mg/5mL

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
60505-6098-1Tigecycline10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1012
60505-6098-1Tigecycline5 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6098-1EA - Each60505-6098a74b7c85-852f-44d7-b4e6-48f570e69fc012019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6098TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOTEX CORP]11Current NDC, Legacy NDC, 2 package rows20250507_230484a8-408c-dcc1-d0c4-d9dd9a46831b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581531tigecycline 50 MG InjectionPSN230484a8-408c-dcc1-d0c4-d9dd9a46831b12
581531tigecycline 50 MG InjectionSCD230484a8-408c-dcc1-d0c4-d9dd9a46831b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6098-16050560980110 VIAL, SINGLE-USE in 1 CARTON (60505-6098-1) / 5 mL in 1 VIAL, SINGLE-USE2019-04-090000-00-00NoNoCurrent