Miconazole 7

Product NDC
70000-0009
11-digit product format
700000009
Labeler code
70000
Product ID
70000-0009_3e750b76-007d-470a-8c7d-5c5f4f6cbbc9
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Cardinal Health (Leader) 70000
Application
ANDA074164
Marketing category
ANDA
Marketing start
2019-07-01
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
70000-0009-1Miconazole 745 g in 1 TUBE, WITH APPLICATORCREAM458
70000-0009-1Miconazole 71 in 1 CARTONCREAM18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0009-1GM - Gram70000-000995dc7871-4066-4485-8022-a615ac7c215112019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0009MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [CARDINAL HEALTH (LEADER) 70000]8Current NDC, Legacy NDC, 2 package rows20240319_5081411c-02d0-4f7d-8496-d6adccbe00ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSN5081411c-02d0-4f7d-8496-d6adccbe00ae8
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD5081411c-02d0-4f7d-8496-d6adccbe00ae8
998540miconazole nitrate 2 % Vaginal CreamSY5081411c-02d0-4f7d-8496-d6adccbe00ae8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0009-1700000009011 TUBE, WITH APPLICATOR in 1 CARTON (70000-0009-1) / 45 g in 1 TUBE, WITH APPLICATOR2019-07-010000-00-00NoNoCurrent