Vancomycin Hydrochloride

Product NDC
70594-047
11-digit product format
705940047
Labeler code
70594
Product ID
70594-047_1dc30561-b506-4282-85ba-e35b802899f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
ANDA204125
Marketing category
ANDA
Marketing start
2019-04-02
Marketing end
0000-00-00
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
5 g/1
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
70594-047-012025-07-29C16284748780-13b156c62-31ae-fb37-e063-e6dba90a4e07Vancomycin Hydrochloride for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70594-047-01Vancomycin Hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,110
70594-047-01Vancomycin Hydrochloride1 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-047-01EA - Each70594-047c0ca9172-3523-40d1-96ed-e8eef088699a12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-047VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]10Legacy NDC, 2 package rows20230916_552fd7cb-fed0-4b48-89bb-674423a37d77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239209vancomycin 100 MG/ML Injectable SolutionPSN552fd7cb-fed0-4b48-89bb-674423a37d7710
313572vancomycin 50 MG/ML Injectable SolutionPSN552fd7cb-fed0-4b48-89bb-674423a37d7710
239209vancomycin 100 MG/ML Injectable SolutionSCD552fd7cb-fed0-4b48-89bb-674423a37d7710
313572vancomycin 50 MG/ML Injectable SolutionSCD552fd7cb-fed0-4b48-89bb-674423a37d7710
239209vancomycin (as vancomycin hydrochloride) 100 MG/ML Injectable SolutionSY552fd7cb-fed0-4b48-89bb-674423a37d7710
313572vancomycin (as vancomycin hydrochloride) 50 MG/ML Injectable SolutionSY552fd7cb-fed0-4b48-89bb-674423a37d7710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70594-047-01705940047011 VIAL, GLASS in 1 CARTON (70594-047-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS2019-04-020000-00-00NoNoCurrent