FDA.reportPublic FDA data

Vancomycin Hydrochloride

Product NDC
69238-2261
11-digit product format
692382261
Labeler code
69238
Product ID
69238-2261_71d25621-053b-45e0-a795-60d19aa5effa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA215338
Marketing category
ANDA
Marketing start
2023-06-26
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
250 mg/5mL
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 HYDROCHLORIDE250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui2000134

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
69238-2261-3Vancomycin Hydrochloride80 mL in 1 BOTTLESOLUTION804
69238-2261-5Vancomycin Hydrochloride300 mL in 1 BOTTLESOLUTION3004
69238-2261-7Vancomycin Hydrochloride150 mL in 1 BOTTLESOLUTION1504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2261-3ML - Milliliter69238-2261683fc41f-c502-4717-be32-00b94c282e7a12023-07-06
69238-2261-5ML - Milliliter69238-2261415b0c5e-9677-43e8-9792-7105be92aca412023-07-06
69238-2261-7ML - Milliliter69238-2261fda07cf1-6491-4b54-b33e-c06b5ea8143d12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2261VANCOMYCIN HYDROCHLORIDE SOLUTION [AMNEAL PHARMACEUTICALS NY LLC]3Current NDC, 3 package rows20230627_3c47d5c4-8cdb-4701-8d7a-8a6e79025b53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2000134vancomycin 50 MG/mL Oral SolutionPSN3c47d5c4-8cdb-4701-8d7a-8a6e79025b534
2000134vancomycin 50 MG/ML Oral SolutionSCD3c47d5c4-8cdb-4701-8d7a-8a6e79025b534
2000134vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral SolutionSY3c47d5c4-8cdb-4701-8d7a-8a6e79025b534
2000134vancomycin 15 GM per 289 ML Powder for Oral SolutionSY3c47d5c4-8cdb-4701-8d7a-8a6e79025b534
2000134vancomycin 250 MG per 5 ML Powder for Oral SolutionSY3c47d5c4-8cdb-4701-8d7a-8a6e79025b534
2000134vancomycin 7.5 GM per 145 ML Powder for Oral SolutionSY3c47d5c4-8cdb-4701-8d7a-8a6e79025b534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-2261-36923822610380 mL in 1 BOTTLE (69238-2261-3) 80 ml2023-06-26NoNoHistorical
69238-2261-569238226105300 mL in 1 BOTTLE (69238-2261-5) 300 ml2023-06-26NoNoHistorical
69238-2261-769238226107150 mL in 1 BOTTLE (69238-2261-7) 150 ml2023-06-26NoNoHistorical