dalbavancin 500 MG Injection

RxCUI: 1539243
RxNorm name: dalbavancin 500 MG Injection
Display name: Dalbavancin (Injectable)
Full name: dalbavancin 500 MG Injection
Term type: SCD
Status: Active
Strength: 500 mg
Dose form: Injection
Route: Injectable
Updated: 2026-09-25 04:22:36

RxNorm Status History#

Status: Active
Source: RXNORM
Current: YES
Release start: 072014
Active start: 072014
Multiple ingredient: NO
Branded: NO

Ingredients And Strength#

Ingredient, Strength, Base table
Ingredient	Strength	Base	Basis of strength
dalbavancin hydrochloride	500 MG / 1 EACH	dalbavancin	dalbavancin

Dose Form Concepts#

Dose form, RxCUI table
Dose form	RxCUI
Injection	1649574

Derived Ingredient Concepts#

Ingredient, RxCUI table
Ingredient	RxCUI
dalbavancin	1539239

Source Vocabulary Codes#

Code type, Values, Count table
Code type	Values	Count	Category
PRESCRIBABLE	Y	1	ATTRIBUTES
RXNAV_STR	dalbavancin 500 MG Injection	1	NAMES
RxNorm Name	dalbavancin 500 MG Injection	1	NAMES
RxNorm Synonym	dalbavancin (as dalbavancin hydrochloride) 500 MG Injection	1	NAMES
TTY	SCD	1	ATTRIBUTES
SPL_SET_ID	6 linked values 1f4a5924-96d7-445a-b75f-2c0e1ffd2dea 2a20d077-a5ba-4af3-a2d6-499c25b816d8 2c2ec45e-48a2-4887-8ab0-9244eb39a394 6c188995-ab05-45c3-a3af-5b1bcd655fdc 966995bb-9d92-434d-b75a-1786072b81c9 f4c0bd0f-03c2-4ce5-bcc2-b58f21ce75c1	6	CODES
RxCUI	1539243	1	CODES
MMSL_CODE	2 linked values BD29632 CD29632	2	CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDC	Product NDC	Name	Labeler	Application
0480-3325-01	0480-3325	Dalbavancin Dalbavancin	Teva Pharmaceuticals, Inc.	ANDA219465
65219-120-12	65219-120	DALBAVANCIN HYDROCHLORIDE DALBAVANCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA217591
71288-034-50	71288-034	Dalbavancin Dalbavancin	Meitheal Pharmaceuticals Inc	ANDA218929
81298-2390-1	81298-2390	Dalbavancin dalbavancin hydrochloride	Long Grove Pharmaceuticals, LLC	ANDA218602

Drugs@FDA Applications#

Application, NDC, Name table
Application	NDC	Name	Marketing category	Labeler
ANDA219465	0480-3325	Dalbavancin Dalbavancin	ANDA	Teva Pharmaceuticals, Inc.
ANDA217591	65219-120	DALBAVANCIN HYDROCHLORIDE DALBAVANCIN HYDROCHLORIDE	ANDA	Fresenius Kabi USA, LLC
ANDA218929	71288-034	Dalbavancin Dalbavancin	ANDA	Meitheal Pharmaceuticals Inc
ANDA218602	81298-2390	Dalbavancin dalbavancin hydrochloride	ANDA	Long Grove Pharmaceuticals, LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 6 matching rows.

NDC11, Source, Active table
NDC11	Source	Active
00480332501	rxnav_ndcs	yes
65219012012	rxnav_ndcs	yes
70069083001	rxnav_ndcs	yes
71288003450	rxnav_ndcs	yes
71839014401	rxnav_ndcs	yes
81298239001	rxnav_ndcs	yes

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dalbavancin	DALBAVANCIN	Somerset Therapeutics, LLC	f4c0bd0f-03c2-4ce5-bcc2-b58f21ce75c1	2026-07-28	Warnings, Adverse reactions	Exact identifier ndc11 (package): 70069083001 rxcui: 1539243
Dalbavancin	DALBAVANCIN	BE Pharmaceuticals Inc.	6c188995-ab05-45c3-a3af-5b1bcd655fdc	2026-06-12	Warnings, Adverse reactions	Exact identifier ndc11 (package): 71839014401 rxcui: 1539243
DALBAVANCIN HYDROCHLORIDE	DALBAVANCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	2c2ec45e-48a2-4887-8ab0-9244eb39a394	2026-04-02	Warnings, Adverse reactions	Exact identifier ndc (package): 65219-120-12 ndc (product): 65219-120 ndc11 (package): 65219012012 rxcui: 1539243
Dalbavancin	DALBAVANCIN HYDROCHLORIDE	Long Grove Pharmaceuticals, LLC	2a20d077-a5ba-4af3-a2d6-499c25b816d8	2026-02-17	Warnings, Adverse reactions	Exact identifier ndc (package): 81298-2390-1 ndc (product): 81298-2390 ndc11 (package): 81298239001 rxcui: 1539243
Dalbavancin	DALBAVANCIN	Meitheal Pharmaceuticals Inc	966995bb-9d92-434d-b75a-1786072b81c9	2025-12-03	Warnings, Adverse reactions	Exact identifier ndc (package): 71288-034-50 ndc (product): 71288-034 ndc11 (package): 71288003450 rxcui: 1539243
Dalbavancin	DALBAVANCIN	Teva Pharmaceuticals, Inc.	1f4a5924-96d7-445a-b75f-2c0e1ffd2dea	2025-10-06	Warnings, Adverse reactions	Exact identifier ndc (package): 0480-3325-01 ndc (product): 0480-3325 ndc11 (package): 00480332501 rxcui: 1539243
DALVANCE	DALBAVANCIN	Allergan, Inc.	4b4674d8-4d1e-4728-8465-d42ada33fa5c	2025-01-13	Warnings, Adverse reactions	Exact identifier rxcui: 1539243

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set ID	RxNorm mappings	Terms	SPL version	Label	Effective
4b4674d8-4d1e-4728-8465-d42ada33fa5c	dalbavancin 500 MG Injection [PSN] · dalbavancin 500 MG Injection [SCD] · dalbavancin (as dalbavancin hydrochloride) 500 MG Injection [SY]	3	29	These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014	20250113
966995bb-9d92-434d-b75a-1786072b81c9	dalbavancin 500 MG Injection [PSN] · dalbavancin 500 MG Injection [SCD] · dalbavancin (as dalbavancin hydrochloride) 500 MG Injection [SY]	3	5	These highlights do not include all the information needed to use DALBAVANCIN FOR INJECTION safely and effectively. See full prescribing information for DALBAVANCIN FOR INJECTION . DALBAVANCIN for injection , for intravenous use Initial U.S. Approval: 2014	20251203
1f4a5924-96d7-445a-b75f-2c0e1ffd2dea	dalbavancin 500 MG Injection [PSN] · dalbavancin 500 MG Injection [SCD] · dalbavancin (as dalbavancin hydrochloride) 500 MG Injection [SY]	3	3	These highlights do not include all the information needed to use DALBAVANCIN FOR INJECTION safely and effectively. See full prescribing information for DALBAVANCIN FOR INJECTION. DALBAVANCIN for injection, for intravenous use Initial U.S. Approval: 2014	20251006
2c2ec45e-48a2-4887-8ab0-9244eb39a394	dalbavancin 500 MG Injection [PSN] · dalbavancin 500 MG Injection [SCD] · dalbavancin (as dalbavancin hydrochloride) 500 MG Injection [SY]	3	2	These highlights do not include all the information needed to use DALBAVANCIN FOR INJECTION safely and effectively. See full prescribing information for DALBAVANCIN FOR INJECTION. DALBAVANCIN for injection, for intravenous use Initial U.S. Approval: 2014	20260402
2a20d077-a5ba-4af3-a2d6-499c25b816d8	dalbavancin 500 MG Injection [PSN] · dalbavancin 500 MG Injection [SCD] · dalbavancin (as dalbavancin hydrochloride) 500 MG Injection [SY]	3	2	These highlights do not include all the information needed to use DALBAVANCIN FOR INJECTION safely and effectively. See full prescribing information for DALBAVANCIN FOR INJECTION. DALBAVANCIN for injection, for intravenous use Initial U.S. Approval: 2014	20260217

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set ID	Title	Manufacturer	Effective
f4c0bd0f-03c2-4ce5-bcc2-b58f21ce75c1	These highlights do not include all the information needed to use DALBAVANCIN FOR INJECTION safely and effectively. See full prescribing information for DALBAVANCIN FOR INJECTION. DALBAVANCIN for injection, for intravenous use Initial U.S. Approval: 2014	Somerset Therapeutics, LLC \| BE BIOSOL PRIVATE LIMITED	20260728
6c188995-ab05-45c3-a3af-5b1bcd655fdc	These highlights do not include all the information needed to use DALBAVANCIN FOR INJECTION safely and effectively. See full prescribing information for DALBAVANCIN FOR INJECTION. DALBAVANCIN for injection, for intravenous use Initial U.S. Approval: 2014	BE Pharmaceuticals Inc. \| BE Biosol Private limited	20260612
2c2ec45e-48a2-4887-8ab0-9244eb39a394	These highlights do not include all the information needed to use DALBAVANCIN FOR INJECTION safely and effectively. See full prescribing information for DALBAVANCIN FOR INJECTION. DALBAVANCIN for injection, for intravenous use Initial U.S. Approval: 2014	Fresenius Kabi USA, LLC	20260402
2a20d077-a5ba-4af3-a2d6-499c25b816d8	These highlights do not include all the information needed to use DALBAVANCIN FOR INJECTION safely and effectively. See full prescribing information for DALBAVANCIN FOR INJECTION. DALBAVANCIN for injection, for intravenous use Initial U.S. Approval: 2014	Long Grove Pharmaceuticals, LLC	20260217
966995bb-9d92-434d-b75a-1786072b81c9	These highlights do not include all the information needed to use DALBAVANCIN FOR INJECTION safely and effectively. See full prescribing information for DALBAVANCIN FOR INJECTION . DALBAVANCIN for injection , for intravenous use Initial U.S. Approval: 2014	Meitheal Pharmaceuticals Inc \| Kindos Pharmaceuticals Co., Ltd.	20251203
2c2ec45e-48a2-4887-8ab0-9244eb39a394	These highlights do not include all the information needed to use DALBAVANCIN FOR INJECTION safely and effectively. See full prescribing information for DALBAVANCIN FOR INJECTION. DALBAVANCIN for injection, for intravenous use Initial U.S. Approval: 2014	Fresenius Kabi USA, LLC	20251106
1f4a5924-96d7-445a-b75f-2c0e1ffd2dea	These highlights do not include all the information needed to use DALBAVANCIN FOR INJECTION safely and effectively. See full prescribing information for DALBAVANCIN FOR INJECTION. DALBAVANCIN for injection, for intravenous use Initial U.S. Approval: 2014	Teva Pharmaceuticals, Inc.	20251006

Drug Classes#

Source, Class ID, Class table
Source	Class ID	Class	Type	Relationship	Drug concept
ATC	J01XA	Glycopeptide antibacterials	ATC1-4		dalbavancin
FDASPL	D000077427	Lipoglycopeptides	CHEM	has_chemical_structure	dalbavancin
FDASPL	N0000191281	Lipoglycopeptide Antibacterial	EPC	has_epc	dalbavancin
MEDRT	D017334	Teicoplanin	CHEM	has_ingredient	dalbavancin
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	dalbavancin
MEDRT	D012874	Skin Diseases, Infectious	DISEASE	may_treat	dalbavancin
MEDRT	D013203	Staphylococcal Infections	DISEASE	may_treat	dalbavancin
MEDRT	D013290	Streptococcal Infections	DISEASE	may_treat	dalbavancin
MEDRT	N0000000150	Protein Synthesis Inhibitors	MOA	has_moa	dalbavancin
MEDRT	N0000008479	Decreased Cell Wall Synthesis & Repair	PE	has_pe	dalbavancin

Group, Type, Concept table
Group	Type	Concept	Source
BN	BN	Dalvance	rxnav_allrelated
DF	DF	Injection	rxnav_allrelated
DFG	DFG	Injectable Product	rxnav_allrelated
IN	IN	dalbavancin	rxnav_allrelated
SBD	SBD	dalbavancin 500 MG Injection [Dalvance]	rxnav_allrelated
SBDC	SBDC	dalbavancin 500 MG [Dalvance]	rxnav_allrelated
SBDF	SBDF	dalbavancin Injection [Dalvance]	rxnav_allrelated
SBDG	SBDG	Dalvance Injectable Product	rxnav_allrelated
SCD	SCD	dalbavancin 500 MG Injection	rxnav_allrelated
SCDC	SCDC	dalbavancin 500 MG	rxnav_allrelated
SCDF	SCDF	dalbavancin Injection	rxnav_allrelated
SCDG	SCDG	dalbavancin Injectable Product	rxnav_allrelated

Properties#

Category, Property, Value table
Category	Property	Value
ATTRIBUTES	AVAILABLE_STRENGTH	500 MG
ATTRIBUTES	GENERAL_CARDINALITY	SINGLE
ATTRIBUTES	HUMAN_DRUG	US
ATTRIBUTES	RXNAV_HUMAN_DRUG	US
ATTRIBUTES	SCHEDULE	0
CODES	ANDA	ANDA217591
CODES	ANDA	ANDA218602
CODES	ANDA	ANDA218929
CODES	ANDA	ANDA219465
CODES	ANDA	ANDA219604
CODES	SNOMEDCT	703920009
CODES	VUID	4033457
NAMES	Prescribable Synonym	dalbavancin 500 MG Injection
SOURCES	Source	Gold Standard Alchemy
SOURCES	Source	Metathesaurus FDA Structured Product Labels
SOURCES	Source	Micromedex RED BOOK
SOURCES	Source	Multum MediSource Lexicon
SOURCES	Source	National Drug Data File Plus Source Vocabulary
SOURCES	Source	US Edition of SNOMED_CT
SOURCES	Source	Veterans Health Administration National Drug File