Vancomycin Hydrochloride

Product NDC
72572-803
11-digit product format
725720803
Labeler code
72572
Product ID
72572-803_4d41d3bd-076a-4bf1-826d-53ad7c2e43ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA204125
Marketing category
ANDA
Marketing start
2019-07-10
Marketing end
0000-00-00
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
5 g/100mL
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
518d3e87-1791-43fd-b421-7f508923e5f1Product name420260107
8c6bdc15-c879-407f-914d-b44fce8e7bbdProduct name120240730
324cd4ef-8967-4991-91fd-3046d51874b9Product name220240118
ba2497d8-e8e9-d71b-251e-24ac323bbaa3Product name920231206
01f96903-8ada-4a91-9a58-9f8e51b7a70aProduct name120230922
e5c5573a-2fda-453b-9d65-c6185b588ecdProduct name520220613
3a86dfd0-ed28-4976-b9ec-00923fbfbdd4Product name120220308
5d603187-d384-6e74-5fc7-30310b2b3c99Product name320190717
bec007f0-8cd6-4f79-a3df-c0d94ebb2a36Product name120190614
f4fec0bc-aaaa-4c5c-aa2b-21daf18ef477Product name120160209
a0c54c75-e1f1-eb4f-25c4-be91c2fe237dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72572-803-012025-07-29C16284748780-13b156c62-3159-fb37-e063-e6dba90a4e07Vancomycin Hydrochloride for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-803-01Vancomycin Hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
72572-803-01Vancomycin Hydrochloride100 mL in 1 BOTTLEINJECTION, POWDER, LYOPHILIZED,1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-803-01EA - Each72572-803f140800a-aa86-40af-bde7-83532e7175bf12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-803VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIVICA, INC.]5Legacy NDC, 2 package rows20240613_be577e5a-4c77-4f4b-bd0e-dfed5975c197.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239209vancomycin 100 MG/ML Injectable SolutionPSNbe577e5a-4c77-4f4b-bd0e-dfed5975c1975
313572vancomycin 50 MG/ML Injectable SolutionPSNbe577e5a-4c77-4f4b-bd0e-dfed5975c1975
239209vancomycin 100 MG/ML Injectable SolutionSCDbe577e5a-4c77-4f4b-bd0e-dfed5975c1975
313572vancomycin 50 MG/ML Injectable SolutionSCDbe577e5a-4c77-4f4b-bd0e-dfed5975c1975
239209vancomycin (as vancomycin hydrochloride) 100 MG/ML Injectable SolutionSYbe577e5a-4c77-4f4b-bd0e-dfed5975c1975
313572vancomycin (as vancomycin hydrochloride) 50 MG/ML Injectable SolutionSYbe577e5a-4c77-4f4b-bd0e-dfed5975c1975

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-803-01725720803011 BOTTLE in 1 CARTON (72572-803-01) > 100 mL in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent