FDA.reportPublic FDA data

METRONIDAZOLE

Product NDC
61919-032
11-digit product format
619190032
Labeler code
61919
Product ID
61919-032_47e13e06-0078-1557-e063-6294a90a5f79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METRONIDAZOLE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA203458
Marketing category
ANDA
Marketing start
2019-08-21
Substance
METRONIDAZOLE
Active strength
500 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
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
61919-032-042026-01-29C16284748780-19d75b9d0-ae40-f424-e053-dadaa90a57ceMETRONIDAZOLE 500mg
61919-032-142026-01-29C16284748780-19d75b9d0-ae40-f424-e053-dadaa90a57ceMETRONIDAZOLE 500mg
61919-032-302022-08-09C16284748780-1ba0f9c33-2803-a910-e053-dadaa90a0b85METRONIDAZOLE 500mg
61919-032-212021-01-29C16284748780-1ba0f9c33-1dff-a910-e053-dadaa90a0b85METRONIDAZOLE
61919-032-302021-01-29C16284748780-1ba0f9c33-2803-a910-e053-dadaa90a0b85METRONIDAZOLE 500mg
61919-032-142020-12-14C16284748780-19d75b9d0-ae40-f424-e053-dadaa90a57ceMETRONIDAZOLE 500mg
61919-032-142020-01-31C16284748780-19d75b9d0-ae40-f424-e053-dadaa90a57ceMETRONIDAZOLE 500mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-032-04METRONIDAZOLE4 in 1 BOTTLETABLET, FILM COATED410
61919-032-14METRONIDAZOLE14 in 1 BOTTLETABLET, FILM COATED1410
61919-032-10METRONIDAZOLE10 in 1 BOTTLETABLET, FILM COATED106
61919-032-30METRONIDAZOLE30 in 1 BOTTLETABLET, FILM COATED303
61919-032-21METRONIDAZOLE21 in 1 BOTTLETABLET, FILM COATED212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-032-04EA - Each61919-032f7e5562b-94db-41dc-aeb8-2089932b084612022-03-09
61919-032-10EA - Each61919-03272f192bf-0584-46f2-a866-3d9155c6f17712019-09-05
61919-032-14EA - Each61919-032dba6604d-76ea-448c-ae5f-417cf758412312017-04-05
61919-032-21EA - Each61919-032c3295f21-366b-4bfc-a44e-23c6bd8cfab412019-09-05
61919-032-30EA - Each61919-032e5c42bfa-e53d-43d4-96ee-df51ca7b85f512019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-032METRONIDAZOLE TABLET, FILM COATED [DIRECT RX]10Current NDC, Legacy NDC, 2 package rows20240110_48836437-c2c2-1ea2-e054-00144ff8d46c.zip
61919-032METRONIDAZOLE TABLET, FILM COATED [DIRECT_RX]5Current NDC, Legacy NDC, 1 package rows20240110_90a5acb3-f8cc-1e82-e053-2995a90a4e97.zip
61919-032METRONIDAZOLE TABLET, FILM COATED [DIRECT_RX]3Current NDC, Legacy NDC, 1 package rows20240110_90a6139b-66e8-7754-e053-2a95a90af815.zip
61919-032METRONIDAZOLE TABLET, FILM COATED [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20220919_90a56d96-a454-3fb3-e053-2a95a90ad291.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSN48836437-c2c2-1ea2-e054-00144ff8d46c10
311681metronidazole 500 MG Oral TabletSCD48836437-c2c2-1ea2-e054-00144ff8d46c10
311681metroNIDAZOLE 500 MG Oral TabletPSN90a5acb3-f8cc-1e82-e053-2995a90a4e976
311681metronidazole 500 MG Oral TabletSCD90a5acb3-f8cc-1e82-e053-2995a90a4e976
311681metroNIDAZOLE 500 MG Oral TabletPSN90a6139b-66e8-7754-e053-2a95a90af8153
311681metronidazole 500 MG Oral TabletSCD90a6139b-66e8-7754-e053-2a95a90af8153
311681metroNIDAZOLE 500 MG Oral TabletPSN90a56d96-a454-3fb3-e053-2a95a90ad2912
311681metronidazole 500 MG Oral TabletSCD90a56d96-a454-3fb3-e053-2a95a90ad2912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-032-04619190032044 TABLET, FILM COATED in 1 BOTTLE (61919-032-04) 2017-02-140000-00-00NoNoCurrent
61919-032-106191900321010 TABLET, FILM COATED in 1 BOTTLE (61919-032-10) 2019-08-210000-00-00NoNoCurrent
61919-032-146191900321414 TABLET, FILM COATED in 1 BOTTLE (61919-032-14) 2017-02-140000-00-00NoNoCurrent
61919-032-216191900322121 in 1 BOTTLEHistorical
61919-032-306191900323030 TABLET, FILM COATED in 1 BOTTLE (61919-032-30) 2019-08-210000-00-00NoNoCurrent