FDA.reportPublic FDA data

metronidazole

Product NDC
70518-3042
11-digit product format
705183042
Labeler code
70518
Product ID
70518-3042_4b1bd76f-cc38-f4ac-e063-6394a90a932a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206560
Marketing category
ANDA
Marketing start
2021-03-09
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3042-02023-03-15C16284748780-1f386c649-fa5e-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
70518-3042-12023-03-15C16284748780-1f386c649-fa5e-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
70518-3042-02023-01-30C16284748780-1f386c649-fa5e-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
70518-3042-12023-01-30C16284748780-1f386c649-fa5e-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3042-0metronidazole21 in 1 BOTTLE, PLASTICTABLET2112
70518-3042-1metronidazole30 in 1 BLISTER PACKTABLET3012
70518-3042-2metronidazole28 in 1 BLISTER PACKTABLET2812
70518-3042-3metronidazole28 in 1 BOTTLE, PLASTICTABLET2812

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3042METRONIDAZOLE TABLET [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 4 package rows20250426_b49a8ad0-2cf9-4386-8bf5-1b1df87b0022.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSNb49a8ad0-2cf9-4386-8bf5-1b1df87b002212
314106metronidazole 250 MG Oral TabletSCDb49a8ad0-2cf9-4386-8bf5-1b1df87b002212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3042-07051830420021 TABLET in 1 BOTTLE, PLASTIC (70518-3042-0) 21 tablet2021-03-090000-00-00NoNoCurrent
70518-3042-17051830420130 TABLET in 1 BLISTER PACK (70518-3042-1) 30 tablet2021-03-230000-00-00NoNoCurrent
70518-3042-27051830420228 TABLET in 1 BLISTER PACK (70518-3042-2) 28 tablet2022-12-05NoNoHistorical
70518-3042-37051830420328 TABLET in 1 BOTTLE, PLASTIC (70518-3042-3) 28 tablet2025-03-25NoNoHistorical