FDA.reportPublic FDA data

Metronidazole

Product NDC
50090-0212
11-digit product format
500900212
Labeler code
50090
Product ID
50090-0212_1a42d883-5685-4c0f-8bbd-11d56d1d75f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203458
Marketing category
ANDA
Marketing start
2014-06-01
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

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
50090-0212-12023-02-07C16284748780-1f386c649-eebe-0266-e053-dadaa90a7c1aMetronidazole Tablets USP
50090-0212-22023-02-07C16284748780-1f386c649-eebe-0266-e053-dadaa90a7c1aMetronidazole Tablets USP
50090-0212-12023-01-30C16284748780-1f386c649-eebe-0266-e053-dadaa90a7c1aMetronidazole Tablets USP
50090-0212-22023-01-30C16284748780-1f386c649-eebe-0266-e053-dadaa90a7c1aMetronidazole Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0212-1Metronidazole30 in 1 BOTTLETABLET, FILM COATED3021
50090-0212-2Metronidazole42 in 1 BOTTLETABLET, FILM COATED4221

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0212-1EA - Each50090-02122649586e-066c-4537-9727-3d8468263fc612018-08-13
50090-0212-2EA - Each50090-02123fcc30e4-2975-4cae-9951-96861b9e2ac912018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0212METRONIDAZOLE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]19Current NDC, Legacy NDC, 2 package rows20230306_60ad086d-6f54-4134-b608-53a6ff571ff8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSN60ad086d-6f54-4134-b608-53a6ff571ff821
311681metronidazole 500 MG Oral TabletSCD60ad086d-6f54-4134-b608-53a6ff571ff821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0212-15009002120130 TABLET, FILM COATED in 1 BOTTLE (50090-0212-1) 2016-06-210000-00-00NoNoCurrent
50090-0212-25009002120242 TABLET, FILM COATED in 1 BOTTLE (50090-0212-2) 2014-11-280000-00-00NoNoCurrent