Miconazole 7

Product NDC
63868-198
11-digit product format
638680198
Labeler code
63868
Product ID
63868-198_d353be3c-4a6d-4c33-b443-1a5fe60a7531
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
ANDA074164
Marketing category
ANDA
Marketing start
2010-07-01
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
63868-198-45Miconazole 71 in 1 CARTONCREAM111
63868-198-45Miconazole 745 g in 1 TUBE, WITH APPLICATORCREAM4511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-198-45GM - Gram63868-198189c5567-160d-42aa-8a98-a0080e8857fd12017-03-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-198MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]11Current NDC, Legacy NDC, 2 package rows20221001_68667d2e-d4d0-46e7-9d84-0f23fdac1cf7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSN68667d2e-d4d0-46e7-9d84-0f23fdac1cf711
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD68667d2e-d4d0-46e7-9d84-0f23fdac1cf711
998540miconazole nitrate 2 % Vaginal CreamSY68667d2e-d4d0-46e7-9d84-0f23fdac1cf711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-198-45638680198451 TUBE, WITH APPLICATOR in 1 CARTON (63868-198-45) / 45 g in 1 TUBE, WITH APPLICATOR2010-07-010000-00-00NoNoCurrent