metronidazole

Product NDC
66993-961
11-digit product format
669930961
Labeler code
66993
Product ID
66993-961_10c57390-98b0-4a9f-8f8d-8d4eb9d16401
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
LOTION
Route
TOPICAL
Labeler
Prasco Laboratories
Application
NDA020901
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-05-28
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-961-59ML - Milliliter66993-96157a28db2-4eaf-4e0c-835a-fdc38c6ec54f12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE LOTION [PRASCO LABORATORIES]2
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE LOTION [PRASCO LABORATORIES]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMETRONIDAZOLE LOTION [PRASCO LABORATORIES]2
CARBOMER HOMOPOLYMER TYPE AINACTIVE INGREDIENTF68VH75CJCMETRONIDAZOLE LOTION [PRASCO LABORATORIES]2
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZMETRONIDAZOLE LOTION [PRASCO LABORATORIES]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMETRONIDAZOLE LOTION [PRASCO LABORATORIES]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4METRONIDAZOLE LOTION [PRASCO LABORATORIES]2
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATMETRONIDAZOLE LOTION [PRASCO LABORATORIES]2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPMETRONIDAZOLE LOTION [PRASCO LABORATORIES]2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RMETRONIDAZOLE LOTION [PRASCO LABORATORIES]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETRONIDAZOLE LOTION [PRASCO LABORATORIES]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4METRONIDAZOLE LOTION [PRASCO LABORATORIES]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMETRONIDAZOLE LOTION [PRASCO LABORATORIES]2
STEARETH-21INACTIVE INGREDIENT53J3F32P58METRONIDAZOLE LOTION [PRASCO LABORATORIES]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YMETRONIDAZOLE LOTION [PRASCO LABORATORIES]2
WATERINACTIVE INGREDIENT059QF0KO0RMETRONIDAZOLE LOTION [PRASCO LABORATORIES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-961METRONIDAZOLE LOTION [PRASCO LABORATORIES]6Legacy NDC20250119_fce3e59e-8e08-47f1-947f-5a6d141ba1b2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-961-59669930961591 BOTTLE in 1 CARTON (66993-961-59) > 59.7 g in 1 BOTTLE1 bottle2009-05-280000-00-00NoNoCurrent