Vancomycin Hydrochloride

Product NDC
68462-956
11-digit product format
684620956
Labeler code
68462
Product ID
68462-956_74056e26-57fd-448e-af76-edbccfc3efb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA205694
Marketing category
ANDA
Marketing start
2026-04-12
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
1 g/20mL
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vancomycin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VANCOMYCIN HYDROCHLORIDE1 g/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui1807513, 1807516

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
68462-956-11Vancomycin Hydrochloride20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,201
68462-956-11Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807513vancomycin 1 GM InjectionPSN74056e26-57fd-448e-af76-edbccfc3efb71
1807516vancomycin 500 MG InjectionPSN74056e26-57fd-448e-af76-edbccfc3efb71
1807513vancomycin 1000 MG InjectionSCD74056e26-57fd-448e-af76-edbccfc3efb71
1807516vancomycin 500 MG InjectionSCD74056e26-57fd-448e-af76-edbccfc3efb71
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSY74056e26-57fd-448e-af76-edbccfc3efb71
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSY74056e26-57fd-448e-af76-edbccfc3efb71
1807513vancomycin 1 GM InjectionSY74056e26-57fd-448e-af76-edbccfc3efb71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-956-116846209561110 VIAL in 1 CARTON (68462-956-11) / 20 mL in 1 VIAL10 vial2026-04-12NoNoCurrent