Sterile Vancomycin Hydrochloride

Product NDC
21695-424
11-digit product format
216950424
Labeler code
21695
Product ID
21695-424_6e8f9e57-8376-4ce5-8ef0-50b3dd3e1168
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Rebel Distributors Corp
Application
ANDA065397
Marketing category
ANDA
Marketing start
2008-12-31
Marketing end
0000-00-00
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
500 mg/10mL
Pharmacologic classes
Glycopeptide Antibacterial [EPC],Glycopeptides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-424-012019-09-24C16284748780-1934fe258-4d79-48b1-e053-8cdaa90a720aSterile Vancomycin Hydrochloride USP 500 mg & 1 g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-424-01Sterile Vancomycin Hydrochloride10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,101

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-424STERILE VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110414_6e8f9e57-8376-4ce5-8ef0-50b3dd3e1168.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807516vancomycin 500 MG InjectionPSN6e8f9e57-8376-4ce5-8ef0-50b3dd3e11681
1807516vancomycin 500 MG InjectionSCD6e8f9e57-8376-4ce5-8ef0-50b3dd3e11681
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSY6e8f9e57-8376-4ce5-8ef0-50b3dd3e11681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-424-012169504240110 mL in 1 VIAL10 mlHistorical