Vancomycin Hydrochloride

Product NDC
63629-1971
11-digit product format
636291971
Labeler code
63629
Product ID
63629-1971_a5f8561d-e4dd-40d3-9d56-9cd92155d1e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA061667
Marketing category
ANDA
Marketing start
2019-09-09
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
63629-1971-1Vancomycin Hydrochloride150 mL in 1 BOTTLEPOWDER, FOR SOLUTION150105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1971-1ML - Milliliter63629-1971cb685aee-507c-47a1-8f61-044a2d4ed2cb12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1971VANCOMYCIN HYDROCHLORIDE POWDER, FOR SOLUTION [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20231110_9b6a7a21-4fde-40c6-a420-a8546a4dc701.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2000134vancomycin 50 MG/mL Oral SolutionPSN9b6a7a21-4fde-40c6-a420-a8546a4dc701105
2000134vancomycin 50 MG/ML Oral SolutionSCD9b6a7a21-4fde-40c6-a420-a8546a4dc701105
2000134vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral SolutionSY9b6a7a21-4fde-40c6-a420-a8546a4dc701105
2000134vancomycin 15 GM per 289 ML Powder for Oral SolutionSY9b6a7a21-4fde-40c6-a420-a8546a4dc701105
2000134vancomycin 250 MG per 5 ML Powder for Oral SolutionSY9b6a7a21-4fde-40c6-a420-a8546a4dc701105
2000134vancomycin 7.5 GM per 145 ML Powder for Oral SolutionSY9b6a7a21-4fde-40c6-a420-a8546a4dc701105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1971-163629197101150 mL in 1 BOTTLE (63629-1971-1) 150 ml2019-09-090000-00-00NoNoCurrent