FDA.reportPublic FDA data

Noritate

Product NDC
0187-5202
11-digit product format
001875202
Labeler code
0187
Product ID
0187-5202_453f532e-bb72-4ea7-b9e5-b9ac903ffafe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
NDA020743
Marketing category
NDA
Marketing start
2013-08-09
Substance
METRONIDAZOLE
Active strength
10 mg/60g
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0187-52020187-5202-35DDiscontinued by firm2026-07-31

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
N020743-001NORITATEMETRONIDAZOLE1%CREAM / TOPICALRLD, RS1997-09-26

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 22:54:322026-06N020743-001NORITATE1%CREAM / TOPICALRLD, RS1997-09-26a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLEOceanside Pharmaceuticalscdf2e251-4bbc-4434-9b00-bef6284491e42022-06-21Adverse reactionsExact identifier
application applno (NDA): 020743
application number: NDA020743
NoritateMETRONIDAZOLEBausch Health US, LLC706b09da-6cf9-421d-8e91-f3999474d3222020-06-01Adverse reactionsExact identifier
application applno (NDA): 020743
application number: NDA020743
ndc (product): 0187-5202

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE10 mg/60g

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
213120Internal RxNorm lookup
311680Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
706b09da-6cf9-421d-8e91-f3999474d322Available 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
a804000f-b74f-0b5d-d17b-aa767c286ddbProduct name120140508
a91ea265-6e02-c08f-93c8-686d54180529Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-5202-35Noritate3.5 g in 1 TUBECREAM3.513
0187-5202-60Noritate1 in 1 CARTONCREAM113
0187-5202-60Noritate60 g in 1 TUBECREAM6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-5202-60GM - Gram0187-5202fed97497-dc25-4392-ac6c-4865e0507e4012013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
metronidazoleACTIVE INGREDIENT140QMO216ENORITATE (METRONIDAZOLE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]5
metronidazoleACTIVE MOIETY140QMO216ENORITATE (METRONIDAZOLE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]5
glycerinINACTIVE INGREDIENTPDC6A3C0OXNORITATE (METRONIDAZOLE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]5
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4NORITATE (METRONIDAZOLE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]5
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNORITATE (METRONIDAZOLE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]5
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNORITATE (METRONIDAZOLE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]5
stearic acidINACTIVE INGREDIENT4ELV7Z65APNORITATE (METRONIDAZOLE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]5
trolamineINACTIVE INGREDIENT9O3K93S3TKNORITATE (METRONIDAZOLE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]5
waterINACTIVE INGREDIENT059QF0KO0RNORITATE (METRONIDAZOLE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-5202NORITATE (METRONIDAZOLE) CREAM [BAUSCH HEALTH US, LLC]13Current NDC, Legacy NDC, 3 package rows20230426_706b09da-6cf9-421d-8e91-f3999474d322.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311680metroNIDAZOLE 1 % Topical CreamPSN706b09da-6cf9-421d-8e91-f3999474d32213
213120Noritate 1 % Topical CreamPSN706b09da-6cf9-421d-8e91-f3999474d32213
213120metronidazole 10 MG/ML Topical Cream [Noritate]SBD706b09da-6cf9-421d-8e91-f3999474d32213
311680metronidazole 10 MG/ML Topical CreamSCD706b09da-6cf9-421d-8e91-f3999474d32213
311680metronidazole 1 % Topical CreamSY706b09da-6cf9-421d-8e91-f3999474d32213
213120Noritate 1 % Topical CreamSY706b09da-6cf9-421d-8e91-f3999474d32213
213120Noritate 10 MG/ML Topical CreamSY706b09da-6cf9-421d-8e91-f3999474d32213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-5202-35001875202353.5 g in 1 TUBE3.5 gHistorical
0187-5202-60001875202601 TUBE in 1 CARTON (0187-5202-60) / 60 g in 1 TUBE1 tube2013-09-080000-00-00NoNoCurrent