FDA.reportPublic FDA data

Vandazole

Product NDC
0245-0860
11-digit product format
002450860
Labeler code
0245
Product ID
0245-0860_44ff0133-9823-f57e-e063-6294a90a5c73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
GEL
Route
VAGINAL
Labeler
Upsher-smith Laboratories, LLC
Application
NDA021806
Marketing category
NDA
Marketing start
2005-10-04
Marketing end
2027-05-31
Substance
METRONIDAZOLE
Active strength
7.5 mg/g
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vandazole

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE7.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui142046, 608934

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55Product name520251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17Product name120250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1Product name520250515
e1aac33b-94ae-4ee9-905b-299f7263853bProduct name320250124
16642716-d28a-4f90-8dcb-3921cd8c8109Product name420240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
0add4de9-d152-3375-3390-1123dddc5e3dProduct name120140508
33ca0fcc-1011-92dc-50a9-a383683eed1eProduct name120140508
53f39d9f-cd3f-04e1-c668-d4580719d57dProduct name120140508
a804000f-b74f-0b5d-d17b-aa767c286ddbProduct name120140508
a91ea265-6e02-c08f-93c8-686d54180529Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0245-0860-70Vandazole70 g in 1 TUBE, WITH APPLICATORGEL7014
0245-0860-70Vandazole1 in 1 CARTONGEL114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-0860-70GM - Gram0245-0860b7099bf7-011a-40b0-973b-9bc8864f68ae12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EVANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.]4
METRONIDAZOLEACTIVE MOIETY140QMO216EVANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KVANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHVANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RVANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0860VANDAZOLE (METRONIDAZOLE) GEL [UPSHER-SMITH LABORATORIES, LLC]13Current NDC, Legacy NDC, 2 package rows20241121_27d71471-8f89-4a1e-8c55-020a58961454.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142046metroNIDAZOLE 0.75 % Vaginal GelPSN27d71471-8f89-4a1e-8c55-020a5896145414
608934VANDAZOLE 0.75 % Vaginal GelPSN27d71471-8f89-4a1e-8c55-020a5896145414
608934metronidazole 0.0075 MG/MG Vaginal Gel [Vandazole]SBD27d71471-8f89-4a1e-8c55-020a5896145414
142046metronidazole 0.0075 MG/MG Vaginal GelSCD27d71471-8f89-4a1e-8c55-020a5896145414
142046metronidazole 0.75 % Vaginal GelSY27d71471-8f89-4a1e-8c55-020a5896145414
608934Vandazole 0.0075 MG/MG Vaginal GelSY27d71471-8f89-4a1e-8c55-020a5896145414
608934Vandazole 0.75 % Vaginal GelSY27d71471-8f89-4a1e-8c55-020a5896145414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0245-0860-70002450860701 TUBE, WITH APPLICATOR in 1 CARTON (0245-0860-70) / 70 g in 1 TUBE, WITH APPLICATOR2005-10-042027-05-31NoNoCurrent