FDA.reportPublic FDA data

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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53002-7341IInactivated by FDA2026-07-31
excluded packagepackage53002-734153002-7341-1IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021806-001VANDAZOLEMETRONIDAZOLE0.75%GEL / VAGINALBXRS2005-05-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N021806-001BX

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021806-001VANDAZOLE0.75%GEL / VAGINALBXRS2005-05-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021806-001BX1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VandazoleMETRONIDAZOLEUpsher-smith Laboratories, LLC27d71471-8f89-4a1e-8c55-020a589614542025-12-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 021806
application number: NDA021806

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-7341-12025-01-30C16284748780-1f386c64a-3108-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VANDAZOLE ® safely and effectively. See full prescribing information for VANDAZOLE. VANDAZOLE ® (metronidazole gel), for intravaginal use Initial U.S. Approval: 1963
53002-7341-12023-06-07C16284748780-1f386c64a-3108-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VANDAZOLE ® safely and effectively. See full prescribing information for VANDAZOLE. VANDAZOLE ® (metronidazole gel), for intravaginal use Initial U.S. Approval: 1963
53002-7341-12023-01-30C16284748780-1f386c64a-3108-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VANDAZOLE ® safely and effectively. See full prescribing information for VANDAZOLE. VANDAZOLE ® (metronidazole gel), for intravaginal use Initial U.S. Approval: 1963

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