FDA.reportPublic FDA data

Metronidazole

Product NDC
71335-1838
11-digit product format
713351838
Labeler code
71335
Product ID
71335-1838_4de87bd8-34c2-40bf-bee0-51bbc9084680
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
250 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1838-0Metronidazole7 in 1 BOTTLETABLET7105
71335-1838-1Metronidazole21 in 1 BOTTLETABLET21105
71335-1838-2Metronidazole30 in 1 BOTTLETABLET30105
71335-1838-3Metronidazole20 in 1 BOTTLETABLET20105
71335-1838-4Metronidazole60 in 1 BOTTLETABLET60105
71335-1838-5Metronidazole28 in 1 BOTTLETABLET28105
71335-1838-6Metronidazole14 in 1 BOTTLETABLET14105
71335-1838-7Metronidazole40 in 1 BOTTLETABLET40105
71335-1838-8Metronidazole42 in 1 BOTTLETABLET42105
71335-1838-9Metronidazole56 in 1 BOTTLETABLET56105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1838METRONIDAZOLE TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 10 package rows20241121_2fa14353-45df-429c-8759-7d66a65f08f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSN2fa14353-45df-429c-8759-7d66a65f08f0105
314106metronidazole 250 MG Oral TabletSCD2fa14353-45df-429c-8759-7d66a65f08f0105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1838-0713351838007 TABLET in 1 BOTTLE (71335-1838-0) 7 tablet2024-10-310000-00-00NoNoCurrent
71335-1838-17133518380121 TABLET in 1 BOTTLE (71335-1838-1) 21 tablet2021-11-230000-00-00NoNoCurrent
71335-1838-27133518380230 TABLET in 1 BOTTLE (71335-1838-2) 30 tablet2021-06-140000-00-00NoNoCurrent
71335-1838-37133518380320 TABLET in 1 BOTTLE (71335-1838-3) 20 tablet2021-05-140000-00-00NoNoCurrent
71335-1838-47133518380460 TABLET in 1 BOTTLE (71335-1838-4) 60 tablet2024-10-310000-00-00NoNoCurrent
71335-1838-57133518380528 TABLET in 1 BOTTLE (71335-1838-5) 28 tablet2021-11-010000-00-00NoNoCurrent
71335-1838-67133518380614 TABLET in 1 BOTTLE (71335-1838-6) 14 tablet2023-12-110000-00-00NoNoCurrent
71335-1838-77133518380740 TABLET in 1 BOTTLE (71335-1838-7) 40 tablet2024-10-310000-00-00NoNoCurrent
71335-1838-87133518380842 TABLET in 1 BOTTLE (71335-1838-8) 42 tablet2024-10-310000-00-00NoNoCurrent
71335-1838-97133518380956 TABLET in 1 BOTTLE (71335-1838-9) 56 tablet2021-04-300000-00-00NoNoCurrent