FDA.reportPublic FDA data

Metronidazole

Product NDC
71335-1922
11-digit product format
713351922
Labeler code
71335
Product ID
71335-1922_cd3ddbd2-3cd3-4bf3-9089-b54f33e52ff1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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
71335-1922-0Metronidazole40 in 1 BOTTLETABLET40105
71335-1922-1Metronidazole20 in 1 BOTTLETABLET20105
71335-1922-2Metronidazole30 in 1 BOTTLETABLET30105
71335-1922-3Metronidazole14 in 1 BOTTLETABLET14105
71335-1922-4Metronidazole56 in 1 BOTTLETABLET56105
71335-1922-5Metronidazole21 in 1 BOTTLETABLET21105
71335-1922-6Metronidazole4 in 1 BOTTLETABLET4105
71335-1922-7Metronidazole28 in 1 BOTTLETABLET28105
71335-1922-8Metronidazole100 in 1 BOTTLETABLET100105
71335-1922-9Metronidazole60 in 1 BOTTLETABLET60105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1922METRONIDAZOLE TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 10 package rows20241121_92e58420-1d99-4a92-b1f3-a7f791ca7187.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSN92e58420-1d99-4a92-b1f3-a7f791ca7187105
311681metronidazole 500 MG Oral TabletSCD92e58420-1d99-4a92-b1f3-a7f791ca7187105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1922-07133519220040 TABLET in 1 BOTTLE (71335-1922-0) 40 tablet2024-10-310000-00-00NoNoCurrent
71335-1922-17133519220120 TABLET in 1 BOTTLE (71335-1922-1) 20 tablet2021-08-110000-00-00NoNoCurrent
71335-1922-27133519220230 TABLET in 1 BOTTLE (71335-1922-2) 30 tablet2021-08-260000-00-00NoNoCurrent
71335-1922-37133519220314 TABLET in 1 BOTTLE (71335-1922-3) 14 tablet2021-10-070000-00-00NoNoCurrent
71335-1922-47133519220456 TABLET in 1 BOTTLE (71335-1922-4) 56 tablet2024-10-310000-00-00NoNoCurrent
71335-1922-57133519220521 TABLET in 1 BOTTLE (71335-1922-5) 21 tablet2021-12-090000-00-00NoNoCurrent
71335-1922-6713351922064 TABLET in 1 BOTTLE (71335-1922-6) 4 tablet2021-10-040000-00-00NoNoCurrent
71335-1922-77133519220728 TABLET in 1 BOTTLE (71335-1922-7) 28 tablet2021-08-030000-00-00NoNoCurrent
71335-1922-871335192208100 TABLET in 1 BOTTLE (71335-1922-8) 100 tablet2024-10-310000-00-00NoNoCurrent
71335-1922-97133519220960 TABLET in 1 BOTTLE (71335-1922-9) 60 tablet2024-10-310000-00-00NoNoCurrent