FDA.reportPublic FDA data

NDC 81298-2390-01 - Dalbavancin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
81298-2390
Requested NDC
81298-2390-01
Package NDCs from labels
81298-2390-1, 81298-2390-01
Manufacturer
Long Grove Pharmaceuticals, LLC
Effective date
2026-02-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dalbavancin - Long Grove Pharmaceuticals, LLCLong Grove Pharmaceuticals, LLC2026-02-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81298-2390-1Dalbavancin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION12
81298-2390-1Dalbavancin1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81298-2390-1EA - Each81298-2390342daf51-2911-4e72-9ecf-312e9305fb9d12026-03-17

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 ยท 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DalbavancinDALBAVANCINSomerset Therapeutics, LLCf4c0bd0f-03c2-4ce5-bcc2-b58f21ce75c12026-07-28Warnings, Adverse reactionsExact identifier
rxcui: 1539243
unii: 33WDQ7T81E
DalbavancinDALBAVANCINBE Pharmaceuticals Inc.6c188995-ab05-45c3-a3af-5b1bcd655fdc2026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 1539243
unii: 33WDQ7T81E
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
DALBAVANCIN HYDROCHLORIDEDALBAVANCIN HYDROCHLORIDEFresenius Kabi USA, LLC2c2ec45e-48a2-4887-8ab0-9244eb39a3942026-04-02Warnings, Adverse reactionsExact identifier
rxcui: 1539243
unii: 33WDQ7T81E
DalbavancinDALBAVANCIN HYDROCHLORIDELong Grove Pharmaceuticals, LLC2a20d077-a5ba-4af3-a2d6-499c25b816d82026-02-17Warnings, Adverse reactionsExact identifier
application number: ANDA218602
ndc (package): 81298-2390-1
ndc (product): 81298-2390
ndc11 (package): 81298239001
rxcui: 1539243
spl id: 3b4d8110-d32a-4c82-9a43-8d3516dd4b1a
spl set id: 2a20d077-a5ba-4af3-a2d6-499c25b816d8
unii: 33WDQ7T81E
DalbavancinDALBAVANCINMeitheal Pharmaceuticals Inc966995bb-9d92-434d-b75a-1786072b81c92025-12-03Warnings, Adverse reactionsExact identifier
rxcui: 1539243
unii: 33WDQ7T81E
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
DalbavancinDALBAVANCINTeva Pharmaceuticals, Inc.1f4a5924-96d7-445a-b75f-2c0e1ffd2dea2025-10-06Warnings, Adverse reactionsExact identifier
rxcui: 1539243
unii: 33WDQ7T81E
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
DALVANCEDALBAVANCINAllergan, Inc.4b4674d8-4d1e-4728-8465-d42ada33fa5c2025-01-13Warnings, Adverse reactionsExact identifier
rxcui: 1539243
unii: 33WDQ7T81E
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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