Metronidazole

Product NDC
72578-129
11-digit product format
725780129
Labeler code
72578
Product ID
72578-129_0310ff7e-f25e-4090-87ac-5a1fc5c5975f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA217128
Marketing category
ANDA
Marketing start
2023-05-31
Substance
METRONIDAZOLE
Active strength
7.5 mg/g
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
METRONIDAZOLE7.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui311678

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
0add4de9-d152-3375-3390-1123dddc5e3dProduct name120140508
33ca0fcc-1011-92dc-50a9-a383683eed1eProduct name120140508
53f39d9f-cd3f-04e1-c668-d4580719d57dProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
a804000f-b74f-0b5d-d17b-aa767c286ddbProduct name120140508
a91ea265-6e02-c08f-93c8-686d54180529Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72578-129-08Metronidazole45 g in 1 TUBECREAM452
72578-129-08Metronidazole1 in 1 CARTONCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-129-08GM - Gram72578-1297db5feda-08ab-4fef-b930-07d9640d815212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-129METRONIDAZOLE CREAM [VIONA PHARMACEUTICALS INC]2Current NDC, 2 package rows20241208_93299502-6cb0-48a4-8190-50fef74bdbee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311678metroNIDAZOLE 0.75 % Topical CreamPSN59e53582-244a-4e9d-b18e-75dddc6a50522
311678metroNIDAZOLE 0.75 % Topical CreamPSN93299502-6cb0-48a4-8190-50fef74bdbee2
311678metronidazole 7.5 MG/ML Topical CreamSCD59e53582-244a-4e9d-b18e-75dddc6a50522
311678metronidazole 7.5 MG/ML Topical CreamSCD93299502-6cb0-48a4-8190-50fef74bdbee2
311678metronidazole 0.75 % Topical CreamSY59e53582-244a-4e9d-b18e-75dddc6a50522
311678metronidazole 0.75 % Topical CreamSY93299502-6cb0-48a4-8190-50fef74bdbee2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72578-129-08725780129081 TUBE in 1 CARTON (72578-129-08) / 45 g in 1 TUBE1 tube2023-05-31NoNoHistorical