FDA.reportPublic FDA data

Nuvessa

Product NDC
0642-7466
11-digit product format
006427466
Labeler code
0642
Product ID
0642-7466_09d13114-f228-f0bc-e063-6394a90a84f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
GEL
Route
TOPICAL
Labeler
Exeltis USA, Inc.
Application
NDA205223
Marketing category
NDA
Marketing start
2018-03-10
Substance
METRONIDAZOLE
Active strength
65 mg/5g
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
N205223-001NUVESSAMETRONIDAZOLE1.3%GEL / VAGINALRLD, RS2014-03-24

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205223-00188777922028-02-02Drug product2015-04-29
N205223-00178930972028-02-19Drug product2015-04-29
N205223-00186586782028-06-27U-16822015-04-29
N205223-001102386342032-06-28Drug product2019-04-25
N205223-001105961552032-06-28Drug product2020-04-07
N205223-00189462762032-06-28U-16642015-03-04
N205223-00191988582032-06-28U-16642015-12-15

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 22:54:322026-06N205223-001NUVESSA1.3%GEL / VAGINALRLD, RS2014-03-24a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N205223-00188777922028-02-02Drug product2015-04-29a50c72e98297…
2026-08-01 22:54:322026-06N205223-00178930972028-02-19Drug product2015-04-29a50c72e98297…
2026-08-01 22:54:322026-06N205223-00186586782028-06-27U-16822015-04-29a50c72e98297…
2026-08-01 22:54:322026-06N205223-001102386342032-06-28Drug product2019-04-25a50c72e98297…
2026-08-01 22:54:322026-06N205223-001105961552032-06-28Drug product2020-04-07a50c72e98297…
2026-08-01 22:54:322026-06N205223-00189462762032-06-28U-16642015-03-04a50c72e98297…
2026-08-01 22:54:322026-06N205223-00191988582032-06-28U-16642015-12-15a50c72e98297…

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
NuvessaMETRONIDAZOLEExeltis USA, Inc.3b6ff39d-f84b-43b3-9b07-c0521c6d79682023-11-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 205223
application number: NDA205223
ndc (product): 0642-7466

Additional Listing Data#

Finished product
Yes
Brand name base
Nuvessa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE65 mg/5g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
140QMO216EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1604336Internal RxNorm lookup
1608253Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b6ff39d-f84b-43b3-9b07-c0521c6d7968Available on FDA.report

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct 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
0642-7466-052023-11-10C16284748780-10191ceaa-6fb7-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use NUVESSA safely and effectively. See full prescribing information for NUVESSA. NUVESSA ® (metronidazole vaginal gel 1.3%) Initial U.S. Approval: 1963
0642-7466-062023-11-10C16284748780-10191ceaa-6fb7-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use NUVESSA safely and effectively. See full prescribing information for NUVESSA. NUVESSA ® (metronidazole vaginal gel 1.3%) Initial U.S. Approval: 1963
0642-7466-052023-07-28C16284748780-10191ceaa-6fb7-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use NUVESSA safely and effectively. See full prescribing information for NUVESSA. NUVESSA ® (metronidazole vaginal gel 1.3%) Initial U.S. Approval: 1963
0642-7466-062023-07-28C16284748780-10191ceaa-6fb7-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use NUVESSA safely and effectively. See full prescribing information for NUVESSA. NUVESSA ® (metronidazole vaginal gel 1.3%) Initial U.S. Approval: 1963

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0642-7466-05Nuvessa5 g in 1 APPLICATORGEL59
0642-7466-05Nuvessa1 in 1 CARTONGEL19
0642-7466-06Nuvessa5 g in 1 APPLICATORGEL59
0642-7466-06Nuvessa1 in 1 CARTONGEL19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0642-7466-05GM - Gram0642-74660afbc000-d420-47b1-88f8-2e2b394d8dad12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0642-7466NUVESSA (METRONIDAZOLE) GEL [EXELTIS USA, INC.]9Current NDC, Legacy NDC, 4 package rows20231111_3b6ff39d-f84b-43b3-9b07-c0521c6d7968.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1608253metroNIDAZOLE 1.3 % Vaginal GelPSN3b6ff39d-f84b-43b3-9b07-c0521c6d79689
1604336NUVESSA 1.3 % Vaginal GelPSN3b6ff39d-f84b-43b3-9b07-c0521c6d79689
1604336metronidazole 0.013 MG/MG Vaginal Gel [Nuvessa]SBD3b6ff39d-f84b-43b3-9b07-c0521c6d79689
1608253metronidazole 0.013 MG/MG Vaginal GelSCD3b6ff39d-f84b-43b3-9b07-c0521c6d79689
1608253metronidazole 1.3 % Vaginal GelSY3b6ff39d-f84b-43b3-9b07-c0521c6d79689
1604336Nuvessa 1.3 % Vaginal GelSY3b6ff39d-f84b-43b3-9b07-c0521c6d79689

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0642-7466-05006427466051 APPLICATOR in 1 CARTON (0642-7466-05) / 5 g in 1 APPLICATOR1 applicator2018-03-100000-00-00NoNoCurrent
0642-7466-06006427466061 APPLICATOR in 1 CARTON (0642-7466-06) / 5 g in 1 APPLICATOR1 applicator2018-03-100000-00-00YesNoCurrent