FDA.reportPublic FDA data

Vancomycin Hydrochloride

Product NDC
0409-6533
11-digit product format
004096533
Labeler code
0409
Product ID
0409-6533_10032a19-0373-4c42-b785-f3d915614e30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VANCOMYCIN HYDROCHLORIDE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA062912
Marketing category
ANDA
Marketing start
2005-03-31
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
1 g/1
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui1807513, 1807516, 1807518, 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
0409-6533-01Vancomycin Hydrochloride10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,1037
0409-6533-11Vancomycin Hydrochloride1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,137
0409-6533-21Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1037
0409-6533-31Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1011
0409-6533-59Vancomycin Hydrochloride1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6533-01EA - Each0409-6533123aa330-1613-47e8-8b64-2d923e829d6112012-07-24
0409-6533-11EA - Each0409-6533607dacf0-0790-424e-80c1-aa54e509249912019-06-19
0409-6533-21EA - Each0409-653334bb68cb-e8e6-4727-9bd7-7c87067b957612021-04-08
0409-6533-31EA - Each0409-6533a4166e67-9554-46e2-b624-307514238adc12020-02-13
0409-6533-49EA - Each0409-65331a1fd307-426e-4620-8ae2-d47604e45a4412012-07-24
0409-6533-59EA - Each0409-6533388228ac-56aa-43f6-a775-15fa6e5d70a712020-02-13
0409-6533-61EA - Each0409-6533b11a7c83-f726-4b5d-a818-fab3acd8c0ce12013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VANCOMYCIN HYDROCHLORIDEACTIVE INGREDIENT71WO621TJDVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
VANCOMYCINACTIVE MOIETY6Q205EH1VUVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
VANCOMYCIN HYDROCHLORIDEACTIVE INGREDIENT71WO621TJDVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1
VANCOMYCINACTIVE MOIETY6Q205EH1VUVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-6533VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]36Current NDC, Legacy NDC, 3 package rows20250109_f2901045-904f-47bd-74a1-c561facd7f25.zip
0409-6533VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]10Current NDC, Legacy NDC, 2 package rows20250117_c9ea31ec-4c26-452f-b07b-c5f894212cd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807513vancomycin 1 GM InjectionPSNf2901045-904f-47bd-74a1-c561facd7f2537
2049890vancomycin 1.5 GM InjectionPSNf2901045-904f-47bd-74a1-c561facd7f2537
1807516vancomycin 500 MG InjectionPSNf2901045-904f-47bd-74a1-c561facd7f2537
1807518vancomycin 750 MG InjectionPSNf2901045-904f-47bd-74a1-c561facd7f2537
1807513vancomycin 1000 MG InjectionSCDf2901045-904f-47bd-74a1-c561facd7f2537
2049890vancomycin 1500 MG InjectionSCDf2901045-904f-47bd-74a1-c561facd7f2537
1807516vancomycin 500 MG InjectionSCDf2901045-904f-47bd-74a1-c561facd7f2537
1807518vancomycin 750 MG InjectionSCDf2901045-904f-47bd-74a1-c561facd7f2537
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSYf2901045-904f-47bd-74a1-c561facd7f2537
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSYf2901045-904f-47bd-74a1-c561facd7f2537
1807513vancomycin 1 GM InjectionSYf2901045-904f-47bd-74a1-c561facd7f2537
2049890vancomycin 1.5 GM (as vancomycin hydrochloride 1.54 GM) InjectionSYf2901045-904f-47bd-74a1-c561facd7f2537
2049890vancomycin 1.5 GM InjectionSYf2901045-904f-47bd-74a1-c561facd7f2537
1807518vancomycin 750 MG (as vancomycin hydrochloride 769 MG) InjectionSYf2901045-904f-47bd-74a1-c561facd7f2537
1807513vancomycin 1 GM InjectionPSNc9ea31ec-4c26-452f-b07b-c5f894212cd511
1807516vancomycin 500 MG InjectionPSNc9ea31ec-4c26-452f-b07b-c5f894212cd511
1807513vancomycin 1000 MG InjectionSCDc9ea31ec-4c26-452f-b07b-c5f894212cd511
1807516vancomycin 500 MG InjectionSCDc9ea31ec-4c26-452f-b07b-c5f894212cd511
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSYc9ea31ec-4c26-452f-b07b-c5f894212cd511
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSYc9ea31ec-4c26-452f-b07b-c5f894212cd511
1807513vancomycin 1 GM InjectionSYc9ea31ec-4c26-452f-b07b-c5f894212cd511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-6533-010040965330110 VIAL in 1 TRAY (0409-6533-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0409-6533-11) 10 vial2005-03-310000-00-00NoNoCurrent
0409-6533-11004096533111 in 1 VIALHistorical
0409-6533-210040965332110 VIAL in 1 CARTON (0409-6533-21) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0409-6533-11) 10 vial2021-03-220000-00-00NoNoCurrent
0409-6533-310040965333110 VIAL in 1 CARTON (0409-6533-31) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0409-6533-59) 10 vial2020-02-180000-00-00NoNoCurrent
0409-6533-59004096533591 in 1 VIALHistorical