FDA.reportPublic FDA data

METROGEL

Product NDC
0299-3820
11-digit product format
002993820
Labeler code
0299
Product ID
0299-3820_c61f8bdc-60b9-4292-a9de-d418c31e9ad7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
GEL
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA021789
Marketing category
NDA
Marketing start
2005-06-30
Marketing end
2026-05-31
Substance
METRONIDAZOLE
Active strength
10 mg/g
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

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
0299-3820-00METROGEL3 g in 1 BLISTER PACKGEL311
0299-3820-01METROGEL55 g in 1 BOTTLE, PUMPGEL5511
0299-3820-03METROGEL3 g in 1 TUBEGEL311
0299-3820-60METROGEL60 g in 1 TUBEGEL6011
0299-3820-99METROGEL55 g in 1 BOTTLE, PUMPGEL5511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-3820-01GM - Gram0299-38205f62a760-8feb-447d-8d9d-ab884e37b8b312012-07-24
0299-3820-60GM - Gram0299-3820eb87c9ef-a86f-4f98-a634-9d0ca6c0518612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.]5
MetronidazoleACTIVE MOIETY140QMO216EMETROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.]5
betadexINACTIVE INGREDIENTJV039JZZ3AMETROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.]5
edetate disodiumINACTIVE INGREDIENT7FLD91C86KMETROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.]5
methylparabenINACTIVE INGREDIENTA2I8C7HI9TMETROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.]5
niacinamideINACTIVE INGREDIENT25X51I8RD4METROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.]5
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TMETROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.]5
propylene glycolINACTIVE INGREDIENT6DC9Q167V3METROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.]5
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHMETROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.]5
waterINACTIVE INGREDIENT059QF0KO0RMETROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.]5
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.]2
MetronidazoleACTIVE MOIETY140QMO216EMETROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.]2
betadexINACTIVE INGREDIENTJV039JZZ3AMETROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.]2
edetate disodiumINACTIVE INGREDIENT7FLD91C86KMETROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TMETROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.]2
niacinamideINACTIVE INGREDIENT25X51I8RD4METROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.]2
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TMETROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3METROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHMETROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RMETROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-3820METROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.]11Current NDC, Legacy NDC, 5 package rows20240420_ab3a8a2d-714a-4beb-af8a-99bc3ac3ebbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
605730MetroGel 1 % Topical GelPSN2b2a552d-ea3c-472c-bf61-f4d878cc48742
577237metroNIDAZOLE 1 % Topical GelPSN2b2a552d-ea3c-472c-bf61-f4d878cc48742
605730metronidazole 0.01 MG/MG Topical Gel [MetroGel]SBD2b2a552d-ea3c-472c-bf61-f4d878cc48742
577237metronidazole 0.01 MG/MG Topical GelSCD2b2a552d-ea3c-472c-bf61-f4d878cc48742
605730MetroGel 0.01 MG/MG Topical GelSY2b2a552d-ea3c-472c-bf61-f4d878cc48742
605730MetroGel 1 % Topical GelSY2b2a552d-ea3c-472c-bf61-f4d878cc48742
577237metronidazole 1 % Topical GelSY2b2a552d-ea3c-472c-bf61-f4d878cc48742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-3820-00002993820003 g in 1 BLISTER PACK (0299-3820-00) 3 g2005-06-300000-00-00NoNoCurrent
0299-3820-010029938200155 g in 1 BOTTLE, PUMP (0299-3820-01) 55 g2011-10-190000-00-00NoNoCurrent
0299-3820-03002993820033 g in 1 TUBE (0299-3820-03) 3 g2005-06-300000-00-00NoNoCurrent
0299-3820-600029938206060 g in 1 TUBE (0299-3820-60) 60 g2006-08-292026-05-31NoNoCurrent
0299-3820-990029938209955 g in 1 BOTTLE, PUMP (0299-3820-99) 55 g2011-10-190000-00-00NoNoCurrent