FDA.reportPublic FDA data

Tigecycline

Product NDC
71288-019
11-digit product format
712880019
Labeler code
71288
Product ID
71288-019_944a7489-75b7-4841-a189-1bb66fa83e30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tigecycline
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA214020
Marketing category
ANDA
Marketing start
2021-05-13
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
Tigecycline
Listing expiration
2026-12-31

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
71288-019-10Tigecycline5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,55
71288-019-11Tigecycline10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,105
71288-019-91Tigecycline5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,51
71288-019-92Tigecycline10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-019-10EA - Each71288-019913c3674-01be-4829-a6bc-e6a8a76bd42a12022-11-07
71288-019-11EA - Each71288-019c77349ae-cf7f-4dee-b993-6c755987caac12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-019TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20210520_4cbefeb0-7d63-4c49-9906-384acc53dd15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581531tigecycline 50 MG InjectionPSN4cbefeb0-7d63-4c49-9906-384acc53dd155
581531tigecycline 50 MG InjectionSCD4cbefeb0-7d63-4c49-9906-384acc53dd155
581531tigecycline 50 MG InjectionPSN6e9a34af-8dee-4ba2-9157-2f5cb46958a91
581531tigecycline 50 MG InjectionSCD6e9a34af-8dee-4ba2-9157-2f5cb46958a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-019-10712880019105 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
71288-019-117128800191110 VIAL, SINGLE-DOSE in 1 CARTON (71288-019-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-019-10) 2021-05-130000-00-00NoNoCurrent
71288-019-91712880019915 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
71288-019-927128800199210 VIAL, SINGLE-DOSE in 1 CARTON (71288-019-92) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-019-91) 2026-04-01NoNoHistorical