Miconazole 7

Product NDC
0904-7734
11-digit product format
009047734
Labeler code
0904
Product ID
0904-7734_3fe3ac94-a530-48d1-a5b4-fa0d607f6deb
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Major Pharmaceuticals
Application
ANDA074164
Marketing category
ANDA
Marketing start
2009-04-21
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Miconazole 7
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998540

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7734-45Miconazole 71 in 1 CARTONCREAM115
0904-7734-45Miconazole 745 g in 1 TUBE, WITH APPLICATORCREAM4515
0904-7734-57Miconazole 745 g in 1 TUBE, WITH APPLICATORCREAM4515
0904-7734-57Miconazole 71 in 1 CARTONCREAM115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7734-45GM - Gram0904-77344a43016b-20c5-40b3-a267-3ac48cc4feb312013-04-01
0904-7734-57GM - Gram0904-7734f1f3afb5-7b3c-454d-ac76-44974288aac612013-04-01

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7734MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [MAJOR PHARMACEUTICALS]15Current NDC, Legacy NDC, 4 package rows20241009_825ac1c5-470e-4ee1-857d-b205c26fc634.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSN825ac1c5-470e-4ee1-857d-b205c26fc63415
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD825ac1c5-470e-4ee1-857d-b205c26fc63415
998540miconazole nitrate 2 % Vaginal CreamSY825ac1c5-470e-4ee1-857d-b205c26fc63415
998540miconazole nitrate 2 % Vaginal CreamPSN85a52081-d9cc-44f0-a8d3-851a45c4eb102
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD85a52081-d9cc-44f0-a8d3-851a45c4eb102
998540miconazole nitrate 2 % Vaginal CreamSY85a52081-d9cc-44f0-a8d3-851a45c4eb102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7734-45009047734451 TUBE, WITH APPLICATOR in 1 CARTON (0904-7734-45) / 45 g in 1 TUBE, WITH APPLICATOR2009-04-210000-00-00NoNoCurrent
0904-7734-570090477345745 g in 1 TUBE, WITH APPLICATOR45 gHistorical