FDA.reportPublic FDA data

Metronidazole

Product NDC
51655-974
11-digit product format
516550974
Labeler code
51655
Product ID
51655-974_4bcf3308-c406-498f-e063-6394a90afc9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METRONIDAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA205245
Marketing category
ANDA
Marketing start
2023-02-28
Substance
METRONIDAZOLE
Active strength
250 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metronidazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui314106

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-974-292026-01-29C16284748780-149896155-c15e-586f-e063-e6dba90add90Metronidazole Tablets, USP Rx only
51655-974-522026-01-29C16284748780-149896155-c15e-586f-e063-e6dba90add90Metronidazole Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-974-29Metronidazole28 in 1 BOTTLE, PLASTICTABLET284
51655-974-52Metronidazole30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-974METRONIDAZOLE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20240814_f7e5dacd-0bc4-4ac4-e053-6394a90a457a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSNf7e5dacd-0bc4-4ac4-e053-6394a90a457a4
314106metronidazole 250 MG Oral TabletSCDf7e5dacd-0bc4-4ac4-e053-6394a90a457a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-974-295165509742928 TABLET in 1 BOTTLE, PLASTIC (51655-974-29) 28 tablet2023-04-03NoNoCurrent
51655-974-525165509745230 TABLET in 1 BOTTLE, PLASTIC (51655-974-52) 30 tablet2023-02-28NoNoCurrent