FDA.reportPublic FDA data

Tygacil

Product NDC
0008-4990
11-digit product format
000084990
Labeler code
0008
Product ID
0008-4990_471458bc-2d5f-470b-a6a4-f4bf0eacf95b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIGECYCLINE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application
NDA021821
Marketing category
NDA
Marketing start
2008-06-15
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
Tygacil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIGECYCLINE50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii70JE2N95KR
Rxcui581531, 584201

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
0008-4990-19Tygacil5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,550
0008-4990-20Tygacil10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1050

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0008-4990-01EA - Each0008-49905394e4a0-2a43-4ad6-a563-e7561e2efaa112016-07-19
0008-4990-02EA - Each0008-4990e4ce5f4e-60ed-41f5-acd4-d5ee796fedd212012-07-24
0008-4990-19EA - Each0008-49909a8e5299-e865-428c-8265-5e0ff19b2f6a12012-07-24
0008-4990-20EA - Each0008-49903ae022f3-6c4a-4b46-b176-d2403349d56412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIGECYCLINEACTIVE INGREDIENT70JE2N95KRTYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]29
TIGECYCLINEACTIVE MOIETY70JE2N95KRTYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]29
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBTYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]29
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]29
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0008-4990TYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]48Current NDC, Legacy NDC, 2 package rows20250501_2ccdb48e-c14a-4eeb-348c-4920ccfd7465.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581531tigecycline 50 MG InjectionPSN2ccdb48e-c14a-4eeb-348c-4920ccfd746550
584201Tygacil 50 MG InjectionPSN2ccdb48e-c14a-4eeb-348c-4920ccfd746550
584201tigecycline 50 MG Injection [Tygacil]SBD2ccdb48e-c14a-4eeb-348c-4920ccfd746550
581531tigecycline 50 MG InjectionSCD2ccdb48e-c14a-4eeb-348c-4920ccfd746550
584201Tygacil 50 MG InjectionSY2ccdb48e-c14a-4eeb-348c-4920ccfd746550

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0008-4990-19000084990195 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
0008-4990-200000849902010 VIAL, SINGLE-DOSE in 1 CARTON (0008-4990-20) / 5 mL in 1 VIAL, SINGLE-DOSE (0008-4990-19) 2009-09-300000-00-00NoNoCurrent