FDA.reportPublic FDA data

Vancomycin Hydrochloride

Product NDC
67457-822
11-digit product format
674570822
Labeler code
67457
Product ID
67457-822_74c1e534-e3d3-430d-8d58-3628160fba3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
NDA209481
Marketing category
NDA
Marketing start
2018-08-31
Marketing end
2022-02-28
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
250 mg/5mL
Pharmacologic classes
Glycopeptide Antibacterial [EPC],Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-822-25Vancomycin Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,512
67457-822-99Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-822-25EA - Each67457-8226da374cc-e9eb-4b89-8d0f-5e021f751d9112018-10-11
67457-822-99EA - Each67457-82263e7d691-8c25-468b-961f-20a09c7a574012018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-822VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]12Legacy NDC, 2 package rows20240731_caf22ccb-df75-45ea-a1d0-ccb2d37272fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049888vancomycin 1.25 GM InjectionPSNcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049890vancomycin 1.5 GM InjectionPSNcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049891vancomycin 250 MG InjectionPSNcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
1807518vancomycin 750 MG InjectionPSNcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049888vancomycin 1250 MG InjectionSCDcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049890vancomycin 1500 MG InjectionSCDcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049891vancomycin 250 MG InjectionSCDcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
1807518vancomycin 750 MG InjectionSCDcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049891vancomycin (as vancomycin hydrochloride) 250 MG InjectionSYcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049888vancomycin 1.25 GM (as vancomycin hydrochloride 1.28 GM) InjectionSYcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049888vancomycin 1.25 GM InjectionSYcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049890vancomycin 1.5 GM (as vancomycin hydrochloride 1.54 GM) InjectionSYcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
2049890vancomycin 1.5 GM InjectionSYcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12
1807518vancomycin 750 MG (as vancomycin hydrochloride 769 MG) InjectionSYcaf22ccb-df75-45ea-a1d0-ccb2d37272fb12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-822-25674570822255 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
67457-822-996745708229910 VIAL, SINGLE-DOSE in 1 CARTON (67457-822-99) > 5 mL in 1 VIAL, SINGLE-DOSE (67457-822-25) 2018-08-312022-02-28NoNoCurrent