FDA.reportPublic FDA data

dalbavancin 500 MG Injection [Dalvance]

RxCUI
1539248
RxNorm name
dalbavancin 500 MG Injection [Dalvance]
Display name
DALVANCE (Injectable)
Full name
dalbavancin 500 MG Injection [Dalvance]
Term type
SBD
Status
Active
Strength
500 mg
Dose form
Injection
Route
Injectable
Updated
2026-09-25 04:22:40

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
072014
Active start
072014
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
dalbavancin hydrochloride500 MG / 1 EACHdalbavancindalbavancin

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Injection1649574

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
dalbavancin1539239

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRDalvance 500 MG Injection1NAMES
RxNorm Namedalbavancin 500 MG Injection [Dalvance]1NAMES
RxNorm SynonymDalvance 500 MG Injection1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID4b4674d8-4d1e-4728-8465-d42ada33fa5c1CODES
RxCUI15392481CODES
MMSL_CODEBD296321CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
57970-100-0157970-100DALVANCE DalbavancinAllergan, Inc.NDA021883

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA02188357970-100DALVANCE DalbavancinNDAAllergan, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 1 matching rows.

NDC11, Source, Active table
NDC11SourceActive
57970010001rxnav_ndcsyes

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DALVANCEDALBAVANCINAllergan, Inc.4b4674d8-4d1e-4728-8465-d42ada33fa5c2025-01-13Warnings, Adverse reactionsExact identifier
ndc (package): 57970-100-01
ndc (product): 57970-100
ndc11 (package): 57970010001
rxcui: 1539248

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
4b4674d8-4d1e-4728-8465-d42ada33fa5cDalvance 500 MG Injection [PSN] · dalbavancin 500 MG Injection [Dalvance] [SBD] · Dalvance 500 MG Injection [SY]329These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 201420250113

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
4b4674d8-4d1e-4728-8465-d42ada33fa5cThese highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014Allergan, Inc.20250113
4b4674d8-4d1e-4728-8465-d42ada33fa5cThese highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014Allergan, Inc.20250113

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCJ01XAGlycopeptide antibacterialsATC1-4dalbavancin
FDASPLD000077427LipoglycopeptidesCHEMhas_chemical_structuredalbavancin
FDASPLN0000191281Lipoglycopeptide AntibacterialEPChas_epcdalbavancin
MEDRTD017334TeicoplaninCHEMhas_ingredientdalbavancin
MEDRTD004342Drug HypersensitivityDISEASEci_withdalbavancin
MEDRTD012874Skin Diseases, InfectiousDISEASEmay_treatdalbavancin
MEDRTD013203Staphylococcal InfectionsDISEASEmay_treatdalbavancin
MEDRTD013290Streptococcal InfectionsDISEASEmay_treatdalbavancin
MEDRTN0000000150Protein Synthesis InhibitorsMOAhas_moadalbavancin
MEDRTN0000008479Decreased Cell Wall Synthesis & RepairPEhas_pedalbavancin

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH500 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA021883
NAMESPrescribable SynonymDalvance 500 MG Injection
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon