FDA.reportPublic FDA data

Vancomycin Hydrochloride

Product NDC
71288-022
11-digit product format
712880022
Labeler code
71288
Product ID
71288-022_8783ba3b-c343-44ba-9a51-516751993478
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA215197
Marketing category
ANDA
Marketing start
2022-07-28
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
500 mg/10mL
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 HYDROCHLORIDE500 mg/10mL

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
71288-022-10Vancomycin Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,105
71288-022-11Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-022-10EA - Each71288-022e690f0b7-d080-48e0-a7fa-c7b7288bbaab12024-07-12
71288-022-11EA - Each71288-022486a87d2-7fa9-4fc5-91cf-e46fcc2ce75b12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-022VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20231220_033efc76-11d5-4a93-91de-56ed41bab9c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807513vancomycin 1 GM InjectionPSN033efc76-11d5-4a93-91de-56ed41bab9c35
1807516vancomycin 500 MG InjectionPSN033efc76-11d5-4a93-91de-56ed41bab9c35
1807513vancomycin 1000 MG InjectionSCD033efc76-11d5-4a93-91de-56ed41bab9c35
1807516vancomycin 500 MG InjectionSCD033efc76-11d5-4a93-91de-56ed41bab9c35
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSY033efc76-11d5-4a93-91de-56ed41bab9c35
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSY033efc76-11d5-4a93-91de-56ed41bab9c35
1807513vancomycin 1 GM InjectionSY033efc76-11d5-4a93-91de-56ed41bab9c35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-022-107128800221010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
71288-022-117128800221110 VIAL, SINGLE-DOSE in 1 CARTON (71288-022-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-022-10) 2022-07-280000-00-00NoNoCurrent