Metronidazole

Product NDC
68682-202
11-digit product format
686820202
Labeler code
68682
Product ID
68682-202_0e74a7e8-92d3-4287-a130-b80624733587
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Oceanside Pharmaceuticals
Application
NDA020743
Marketing category
NDA
Marketing start
2023-08-01
Substance
METRONIDAZOLE
Active strength
10 mg/60g
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
METRONIDAZOLE10 mg/60g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui311680

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
68682-202-60Metronidazole60 g in 1 TUBECREAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-202METRONIDAZOLE CREAM [OCEANSIDE PHARMACEUTICALS]2Current NDC, 1 package rows20230801_cdf2e251-4bbc-4434-9b00-bef6284491e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311680metroNIDAZOLE 1 % Topical CreamPSNcdf2e251-4bbc-4434-9b00-bef6284491e42
311680metronidazole 10 MG/ML Topical CreamSCDcdf2e251-4bbc-4434-9b00-bef6284491e42
311680metronidazole 1 % Topical CreamSYcdf2e251-4bbc-4434-9b00-bef6284491e42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68682-202-606868202026060 g in 1 TUBE (68682-202-60) 60 g2023-08-01NoNoHistorical