Home NDC 71839-144 Dalbavancin
Product NDC 71839-144
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219604-001 DALBAVANCIN HYDROCHLORIDE DALBAVANCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2026-06-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219604-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A219604-001 DALBAVANCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2026-06-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219604-001 DALBAVANCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2026-06-04 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219604-001 DALBAVANCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2026-06-04 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A219604-001 AP 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219604-001 AP 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219604-001 AP 1 a50c72e98297…
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 Ingredient Strength DALBAVANCIN HYDROCHLORIDE 500 mg/25mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 33WDQ7T81E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1539243 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 71839-144-01 71839014401 1 VIAL in 1 CARTON (71839-144-01) / 25 mL in 1 VIAL 1 vial 2026-06-12 0 Current