FDA.reportPublic FDA data

Dalbavancin

Product NDC
71288-034
11-digit product format
712880034
Labeler code
71288
Product ID
71288-034_eb1f6798-3443-4fa7-95fc-fe4a387de46d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dalbavancin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc
Application
ANDA218929
Marketing category
ANDA
Marketing start
2025-11-26
Substance
DALBAVANCIN HYDROCHLORIDE
Active strength
500 mg/25mL
Pharmacologic classes
Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
A218929-001DALBAVANCIN HYDROCHLORIDEDALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2025-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218929-001AP

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 UTC2026-02A218929-001DALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2025-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218929-001DALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2025-11-2631067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218929-001DALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2025-11-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218929-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218929-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218929-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Dalbavancin
Listing expiration
2026-12-31

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
966995bb-9d92-434d-b75a-1786072b81c9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7d1fcb9d-f525-416f-bfa8-1723d8a02331Product name120151224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-034-50Dalbavancin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
71288-034-50Dalbavancin25 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-034-50EA - Each71288-0345dfe17a7-6070-4c9f-94a1-f54be4caf5eb12025-12-16

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
DalbavancinDALBAVANCINMeitheal Pharmaceuticals Inc966995bb-9d92-434d-b75a-1786072b81c92025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218929
application number: ANDA218929
ndc (product): 71288-034

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1539243dalbavancin 500 MG InjectionPSN966995bb-9d92-434d-b75a-1786072b81c95
1539243dalbavancin 500 MG InjectionSCD966995bb-9d92-434d-b75a-1786072b81c95
1539243dalbavancin (as dalbavancin hydrochloride) 500 MG InjectionSY966995bb-9d92-434d-b75a-1786072b81c95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-034-50712880034501 VIAL, SINGLE-DOSE in 1 CARTON (71288-034-50) / 25 mL in 1 VIAL, SINGLE-DOSE2025-11-26NoNoCurrent