FDA.reportPublic FDA data

Dalbavancin

Product NDC
71839-144
Requested package NDC
71839-144-01
11-digit product format
718390144
Labeler code
71839
Product ID
71839-144_02c586bb-801d-4e84-a155-b862b5758937
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dalbavancin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BE Pharmaceuticals Inc.
Application
ANDA219604
Marketing category
ANDA
Marketing start
2026-06-12
Substance
DALBAVANCIN HYDROCHLORIDE
Active strength
500 mg/25mL
Pharmacologic classes
Lipoglycopeptide Antibacterial [EPC]; Lipoglycopeptides [CS]
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A219604-001DALBAVANCIN HYDROCHLORIDEDALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2026-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219604-001AP

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
2026-09-14 22:38:342026-08A219604-001DALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2026-06-0484e616aacf4f…
2026-08-18 06:07:402026-07A219604-001DALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2026-06-04caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219604-001DALBAVANCIN HYDROCHLORIDEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2026-06-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219604-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A219604-001AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219604-001AP1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Dalbavancin
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
6c188995-ab05-45c3-a3af-5b1bcd655fdcAvailable on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DalbavancinDALBAVANCINSomerset Therapeutics, LLCf4c0bd0f-03c2-4ce5-bcc2-b58f21ce75c12026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219604
application number: ANDA219604
DalbavancinDALBAVANCINBE Pharmaceuticals Inc.6c188995-ab05-45c3-a3af-5b1bcd655fdc2026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219604
application number: ANDA219604
ndc (package): 71839-144-01
ndc (product): 71839-144
ndc11 (package): 71839014401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
71839-144-01718390144011 VIAL in 1 CARTON (71839-144-01) / 25 mL in 1 VIAL1 vial2026-06-120Current