FDA.reportPublic FDA data

Vancomycin Hydrochloride

Product NDC
25021-147
11-digit product format
250210147
Labeler code
25021
Product ID
25021-147_a05d9267-0d03-44f5-ae26-e7a523b5b862
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA218140
Marketing category
ANDA
Marketing start
2025-06-01
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
750 mg/15mL
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/15mL

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
25021-147-20Vancomycin Hydrochloride15 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,151
25021-147-20Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-147-20EA - Each25021-1474dd01289-6392-46ce-a94e-174d474bdf3e12025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049888vancomycin 1.25 GM InjectionPSNf623889c-a47a-4b3a-b3a9-e04051f5c2df1
2049890vancomycin 1.5 GM InjectionPSNf623889c-a47a-4b3a-b3a9-e04051f5c2df1
1807518vancomycin 750 MG InjectionPSNf623889c-a47a-4b3a-b3a9-e04051f5c2df1
2049888vancomycin 1250 MG InjectionSCDf623889c-a47a-4b3a-b3a9-e04051f5c2df1
2049890vancomycin 1500 MG InjectionSCDf623889c-a47a-4b3a-b3a9-e04051f5c2df1
1807518vancomycin 750 MG InjectionSCDf623889c-a47a-4b3a-b3a9-e04051f5c2df1
2049888vancomycin 1.25 GM (as vancomycin hydrochloride 1.28 GM) InjectionSYf623889c-a47a-4b3a-b3a9-e04051f5c2df1
2049888vancomycin 1.25 GM InjectionSYf623889c-a47a-4b3a-b3a9-e04051f5c2df1
2049890vancomycin 1.5 GM (as vancomycin hydrochloride 1.54 GM) InjectionSYf623889c-a47a-4b3a-b3a9-e04051f5c2df1
2049890vancomycin 1.5 GM InjectionSYf623889c-a47a-4b3a-b3a9-e04051f5c2df1
1807518vancomycin 750 MG (as vancomycin hydrochloride 769 MG) InjectionSYf623889c-a47a-4b3a-b3a9-e04051f5c2df1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-147-202502101472010 VIAL in 1 CARTON (25021-147-20) / 15 mL in 1 VIAL10 vial2025-06-01NoNoCurrent