FDA.reportPublic FDA data

Vancomycin Hydrochloride

Product NDC
68462-477
11-digit product format
684620477
Labeler code
68462
Product ID
68462-477_210eb04c-a542-44da-b4a3-7e243186b483
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA218140
Marketing category
ANDA
Marketing start
2025-03-21
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
750 mg/1
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vancomycin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VANCOMYCIN HYDROCHLORIDE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui1807518, 2049888, 2049890

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
68462-477-20Vancomycin Hydrochloride1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,13
68462-477-74Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-477VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLENMARK PHARMACEUTICALS INC., USA]2Current NDC, 2 package rows20250427_0543b2b5-b1c7-4ad6-b38c-3be0086f0e06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049888vancomycin 1.25 GM InjectionPSN0543b2b5-b1c7-4ad6-b38c-3be0086f0e063
2049890vancomycin 1.5 GM InjectionPSN0543b2b5-b1c7-4ad6-b38c-3be0086f0e063
1807518vancomycin 750 MG InjectionPSN0543b2b5-b1c7-4ad6-b38c-3be0086f0e063
2049888vancomycin 1250 MG InjectionSCD0543b2b5-b1c7-4ad6-b38c-3be0086f0e063
2049890vancomycin 1500 MG InjectionSCD0543b2b5-b1c7-4ad6-b38c-3be0086f0e063
1807518vancomycin 750 MG InjectionSCD0543b2b5-b1c7-4ad6-b38c-3be0086f0e063
2049888vancomycin 1.25 GM (as vancomycin hydrochloride 1.28 GM) InjectionSY0543b2b5-b1c7-4ad6-b38c-3be0086f0e063
2049888vancomycin 1.25 GM InjectionSY0543b2b5-b1c7-4ad6-b38c-3be0086f0e063
2049890vancomycin 1.5 GM (as vancomycin hydrochloride 1.54 GM) InjectionSY0543b2b5-b1c7-4ad6-b38c-3be0086f0e063
2049890vancomycin 1.5 GM InjectionSY0543b2b5-b1c7-4ad6-b38c-3be0086f0e063
1807518vancomycin 750 MG (as vancomycin hydrochloride 769 MG) InjectionSY0543b2b5-b1c7-4ad6-b38c-3be0086f0e063

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68462-477-20684620477201 in 1 VIAL, SINGLE-DOSEHistorical
68462-477-746846204777410 VIAL, SINGLE-DOSE in 1 CARTON (68462-477-74) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68462-477-20) 2025-03-21NoNoCurrent