FDA.reportPublic FDA data

Tigecycline

Product NDC
70121-1647
11-digit product format
701211647
Labeler code
70121
Product ID
70121-1647_c21de58f-dcd0-46f7-a6d9-0ff5ba5863a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tigecycline
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
NDA211158
Marketing category
NDA
Marketing start
2018-01-31
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
70121-1647-1Tigecycline5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,519
70121-1647-7Tigecycline10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1647-1EA - Each70121-1647d05ef98e-625c-45fb-b545-ee1b2ec5dc5612019-09-05
70121-1647-7EA - Each70121-1647092a9b7e-e4bc-4f55-ae46-99bf141b262b12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1647TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]19Current NDC, Legacy NDC, 2 package rows20250403_8450bd15-2b06-4fc7-b302-9021312e3f0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581531tigecycline 50 MG InjectionPSN8450bd15-2b06-4fc7-b302-9021312e3f0d19
581531tigecycline 50 MG InjectionSCD8450bd15-2b06-4fc7-b302-9021312e3f0d19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1647-1701211647015 mL in 1 VIAL5 mlHistorical
70121-1647-77012116470710 VIAL in 1 CARTON (70121-1647-7) / 5 mL in 1 VIAL (70121-1647-1) 10 vial2018-01-310000-00-00NoNoCurrent