FDA.reportPublic FDA data

metronidazole

Product NDC
69292-208
11-digit product format
692920208
Labeler code
69292
Product ID
69292-208_7287076f-6345-40c4-8ced-5b3cae45b7a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
AMICI PHARMA INC
Application
ANDA070772
Marketing category
ANDA
Marketing start
2019-11-22
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
69292-208-01metronidazole100 in 1 BOTTLETABLET1006
69292-208-50metronidazole500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-208-50EA - Each69292-2087acecca5-1d36-470b-a17b-f922bf7f277c12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69292-208METRONIDAZOLE TABLET [AMICI PHARMA INC]6Current NDC, Legacy NDC, 2 package rows20250413_9f1fec88-097f-42b9-a36f-214648d7eebb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNa6ce16b7-25c5-48aa-e053-2a95a90aa9478
311681metronidazole 500 MG Oral TabletSCDa6ce16b7-25c5-48aa-e053-2a95a90aa9478
314106metroNIDAZOLE 250 MG Oral TabletPSNc90da73c-e48e-411a-bd75-0b107f1141cc7
311681metroNIDAZOLE 500 MG Oral TabletPSNc90da73c-e48e-411a-bd75-0b107f1141cc7
314106metronidazole 250 MG Oral TabletSCDc90da73c-e48e-411a-bd75-0b107f1141cc7
311681metronidazole 500 MG Oral TabletSCDc90da73c-e48e-411a-bd75-0b107f1141cc7
311681metroNIDAZOLE 500 MG Oral TabletPSN9f1fec88-097f-42b9-a36f-214648d7eebb6
311681metronidazole 500 MG Oral TabletSCD9f1fec88-097f-42b9-a36f-214648d7eebb6
311681metroNIDAZOLE 500 MG Oral TabletPSNafed6bd4-7c91-6543-e053-2995a90a1bd73
311681metronidazole 500 MG Oral TabletSCDafed6bd4-7c91-6543-e053-2995a90a1bd73
311681metroNIDAZOLE 500 MG Oral TabletPSNb558d620-fb67-16eb-e053-2995a90a04fe2
311681metronidazole 500 MG Oral TabletSCDb558d620-fb67-16eb-e053-2995a90a04fe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69292-208-0169292020801100 TABLET in 1 BOTTLE (69292-208-01) 100 tablet2019-11-220000-00-00NoNoCurrent
69292-208-5069292020850500 TABLET in 1 BOTTLE (69292-208-50) 500 tablet2019-11-220000-00-00NoNoCurrent