FDA.reportPublic FDA data

DALBAVANCIN HYDROCHLORIDE

Product NDC
65219-120
11-digit product format
652190120
Labeler code
65219
Product ID
65219-120_e9e7ab64-7f96-41c4-abb4-f71b77e60245
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DALBAVANCIN HYDROCHLORIDE
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA217591
Marketing category
ANDA
Marketing start
2025-11-10
Substance
DALBAVANCIN HYDROCHLORIDE
Active strength
500 mg/25mL
Pharmacologic classes
Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217591-001DALBAVANCIN HYDROCHLORIDEDALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2025-11-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217591-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217591-001DALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2025-11-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217591-001DALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2025-11-1031067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217591-001DALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2025-11-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217591-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217591-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217591-001AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DALBAVANCIN HYDROCHLORIDE500 mg/25mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33WDQ7T81EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1539243Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c2ec45e-48a2-4887-8ab0-9244eb39a394Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
7d1fcb9d-f525-416f-bfa8-1723d8a02331Product name120151224
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-120-12DALBAVANCIN HYDROCHLORIDE25 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION252
65219-120-12DALBAVANCIN HYDROCHLORIDE1 in 1 PACKAGEINJECTION, POWDER, FOR SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-120-12EA - Each65219-12020e93a2c-32d0-499a-81c3-6a9edf9fc91612025-12-16

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
DALBAVANCIN HYDROCHLORIDEDALBAVANCIN HYDROCHLORIDEFresenius Kabi USA, LLC2c2ec45e-48a2-4887-8ab0-9244eb39a3942026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217591
application number: ANDA217591
ndc (product): 65219-120

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1539243dalbavancin 500 MG InjectionPSN2c2ec45e-48a2-4887-8ab0-9244eb39a3942
1539243dalbavancin 500 MG InjectionSCD2c2ec45e-48a2-4887-8ab0-9244eb39a3942
1539243dalbavancin (as dalbavancin hydrochloride) 500 MG InjectionSY2c2ec45e-48a2-4887-8ab0-9244eb39a3942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-120-12652190120121 VIAL in 1 PACKAGE (65219-120-12) / 25 mL in 1 VIAL1 vial2025-11-10NoNoCurrent