FDA.reportPublic FDA data

VANCOMYCIN HYDROCHLORIDE

Product NDC
70436-021
11-digit product format
704360021
Labeler code
70436
Product ID
70436-021_51d75e09-0b72-7ecb-e063-6294a90aee46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VANCOMYCIN HYDROCHLORIDE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA212332
Marketing category
ANDA
Marketing start
2019-06-03
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

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
70436-021-82VANCOMYCIN HYDROCHLORIDE10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,109
70436-021-82VANCOMYCIN HYDROCHLORIDE1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-021VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC]8Current NDC, Legacy NDC, 2 package rows20210731_57f58371-3ce6-4983-89df-acba33d1139a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807513vancomycin 1 GM InjectionPSN57f58371-3ce6-4983-89df-acba33d1139a9
1807516vancomycin 500 MG InjectionPSN57f58371-3ce6-4983-89df-acba33d1139a9
1807513vancomycin 1000 MG InjectionSCD57f58371-3ce6-4983-89df-acba33d1139a9
1807516vancomycin 500 MG InjectionSCD57f58371-3ce6-4983-89df-acba33d1139a9
1807513vancomycin (as vancomycin HCl) 1 GM InjectionSY57f58371-3ce6-4983-89df-acba33d1139a9
1807516vancomycin (as vancomycin HCl) 500 MG InjectionSY57f58371-3ce6-4983-89df-acba33d1139a9
1807513vancomycin 1 GM InjectionSY57f58371-3ce6-4983-89df-acba33d1139a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70436-021-827043600218210 VIAL in 1 CARTON (70436-021-82) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL10 vial2019-06-030000-00-00NoNoCurrent