FDA.reportPublic FDA data

metronidazole

Product NDC
69292-207
11-digit product format
692920207
Labeler code
69292
Product ID
69292-207_ea93595d-72b5-4df4-8251-3e66be6db5d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
AMICI PHARMA INC
Application
ANDA070772
Marketing category
ANDA
Marketing start
2019-08-26
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
Rxcui311681, 314106

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
69292-207-01metronidazole100 in 1 BOTTLETABLET10015
69292-207-50metronidazole500 in 1 BOTTLETABLET50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-207-50EA - Each69292-207800eef5a-0a92-4787-9bbe-5cc1fb69353712019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69292-207METRONIDAZOLE TABLET [AMICI PHARMA INC]15Current NDC, Legacy NDC, 2 package rows20250413_4920fcf7-5ceb-46e9-82e0-dc508900bb91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSN4920fcf7-5ceb-46e9-82e0-dc508900bb9115
311681metroNIDAZOLE 500 MG Oral TabletPSN4920fcf7-5ceb-46e9-82e0-dc508900bb9115
314106metronidazole 250 MG Oral TabletSCD4920fcf7-5ceb-46e9-82e0-dc508900bb9115
311681metronidazole 500 MG Oral TabletSCD4920fcf7-5ceb-46e9-82e0-dc508900bb9115
314106metroNIDAZOLE 250 MG Oral TabletPSNa6ceb47b-d0b0-d377-e053-2995a90a463e8
314106metronidazole 250 MG Oral TabletSCDa6ceb47b-d0b0-d377-e053-2995a90a463e8
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69292-207-0169292020701100 TABLET in 1 BOTTLE (69292-207-01) 100 tablet2019-08-260000-00-00NoNoCurrent
69292-207-5069292020750500 TABLET in 1 BOTTLE (69292-207-50) 500 tablet2019-08-260000-00-00NoNoCurrent