Vandazole

Product NDC
53002-7341
11-digit product format
530027341
Labeler code
53002
Product ID
53002-7341_e9fa2ca4-4971-445c-80b6-7f5e91ed9374
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
GEL
Route
VAGINAL
Labeler
RPK Pharmaceuticals, Inc.
Application
NDA021806
Marketing category
NDA
Marketing start
2005-10-04
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
8 mg/g
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-7341-1Vandazole1 in 1 CARTONGEL13
53002-7341-1Vandazole70 g in 1 TUBE, WITH APPLICATORGEL703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-7341VANDAZOLE (METRONIDAZOLE) GEL [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20230609_07c9336a-77e0-4cba-b01b-07917c05ec1a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-7341-1530027341011 TUBE, WITH APPLICATOR in 1 CARTON (53002-7341-1) > 70 g in 1 TUBE, WITH APPLICATOR2019-06-010000-00-00NoNoCurrent