FDA.reportPublic FDA data

Metronidazole

Product NDC
65862-695
11-digit product format
658620695
Labeler code
65862
Product ID
65862-695_f56928ba-4263-4212-ae2e-d89fcc7bea68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203974
Marketing category
ANDA
Marketing start
2015-05-29
Substance
METRONIDAZOLE
Active strength
500 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui311681, 314106

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
65862-695-01Metronidazole100 in 1 BOTTLETABLET10013
65862-695-05Metronidazole500 in 1 BOTTLETABLET50013
65862-695-50Metronidazole50 in 1 BOTTLETABLET5013
65862-695-99Metronidazole1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-695-01EA - Each65862-6958fa4709d-4ec6-4276-93f6-4b5666d7f12212015-09-10
65862-695-05EA - Each65862-69597f2539c-7f4e-4cdc-af68-c75a95d032be12015-09-10
65862-695-50EA - Each65862-69595ce857a-813c-4236-a560-3fbd5e0e0a1012015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [AUROBINDO PHARMA LIMITED]3
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [AUROBINDO PHARMA LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [AUROBINDO PHARMA LIMITED]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMETRONIDAZOLE TABLET [AUROBINDO PHARMA LIMITED]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [AUROBINDO PHARMA LIMITED]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METRONIDAZOLE TABLET [AUROBINDO PHARMA LIMITED]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETRONIDAZOLE TABLET [AUROBINDO PHARMA LIMITED]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMETRONIDAZOLE TABLET [AUROBINDO PHARMA LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-695METRONIDAZOLE TABLET [AUROBINDO PHARMA LIMITED]13Current NDC, Legacy NDC, 4 package rows20240906_f68397ee-67db-472e-8607-4300064e37df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSNf68397ee-67db-472e-8607-4300064e37df13
311681metroNIDAZOLE 500 MG Oral TabletPSNf68397ee-67db-472e-8607-4300064e37df13
314106metronidazole 250 MG Oral TabletSCDf68397ee-67db-472e-8607-4300064e37df13
311681metronidazole 500 MG Oral TabletSCDf68397ee-67db-472e-8607-4300064e37df13
311681metroNIDAZOLE 500 MG Oral TabletPSN50486587-8f8e-1f9e-e054-00144ff8d46c5
311681metronidazole 500 MG Oral TabletSCD50486587-8f8e-1f9e-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-695-0165862069501100 TABLET in 1 BOTTLE (65862-695-01) 100 tablet2015-05-290000-00-00NoNoCurrent
65862-695-0565862069505500 TABLET in 1 BOTTLE (65862-695-05) 500 tablet2015-05-290000-00-00NoNoCurrent
65862-695-506586206955050 TABLET in 1 BOTTLE (65862-695-50) 50 tablet2015-05-290000-00-00NoNoCurrent
65862-695-99658620695991000 TABLET in 1 BOTTLE (65862-695-99) 1000 tablet2015-05-290000-00-00NoNoCurrent