METRONIDAZOLE

Product NDC
66993-960
11-digit product format
669930960
Labeler code
66993
Product ID
66993-960_47d8cbcd-bd51-4931-a912-949721c2749d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METRONIDAZOLE
Dosage form
CREAM
Route
TOPICAL
Labeler
Prasco Laboratories
Application
NDA020531
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-06-18
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
METRONIDAZOLE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE7.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui311678

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
0add4de9-d152-3375-3390-1123dddc5e3dProduct name120140508
33ca0fcc-1011-92dc-50a9-a383683eed1eProduct name120140508
53f39d9f-cd3f-04e1-c668-d4580719d57dProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
a804000f-b74f-0b5d-d17b-aa767c286ddbProduct name120140508
a91ea265-6e02-c08f-93c8-686d54180529Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66993-960-45METRONIDAZOLE45 g in 1 TUBECREAM455
66993-960-45METRONIDAZOLE1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-960-45GM - Gram66993-96002272dcb-682f-48b5-91a0-6fbb75b0f01612014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE CREAM [PRASCO LABORATORIES]1
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE CREAM [PRASCO LABORATORIES]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMETRONIDAZOLE CREAM [PRASCO LABORATORIES]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMETRONIDAZOLE CREAM [PRASCO LABORATORIES]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MMETRONIDAZOLE CREAM [PRASCO LABORATORIES]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATMETRONIDAZOLE CREAM [PRASCO LABORATORIES]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMETRONIDAZOLE CREAM [PRASCO LABORATORIES]1
SORBITOLINACTIVE INGREDIENT506T60A25RMETRONIDAZOLE CREAM [PRASCO LABORATORIES]1
WATERINACTIVE INGREDIENT059QF0KO0RMETRONIDAZOLE CREAM [PRASCO LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-960METRONIDAZOLE CREAM [PRASCO LABORATORIES]5Current NDC, Legacy NDC, 2 package rows20241116_a6ce81f5-a5c6-44d7-b5f0-61d0530345bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311678metroNIDAZOLE 0.75 % Topical CreamPSNa6ce81f5-a5c6-44d7-b5f0-61d0530345bd5
311678metronidazole 7.5 MG/ML Topical CreamSCDa6ce81f5-a5c6-44d7-b5f0-61d0530345bd5
311678metronidazole 0.75 % Topical CreamSYa6ce81f5-a5c6-44d7-b5f0-61d0530345bd5
311678metroNIDAZOLE 0.75 % Topical CreamPSNd39922f0-c37c-fec3-e053-2995a90a141c2
311678metronidazole 7.5 MG/ML Topical CreamSCDd39922f0-c37c-fec3-e053-2995a90a141c2
311678metronidazole 0.75 % Topical CreamSYd39922f0-c37c-fec3-e053-2995a90a141c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-960-45669930960451 TUBE in 1 CARTON (66993-960-45) / 45 g in 1 TUBE1 tube2009-06-182027-05-31NoNoCurrent