FDA.reportPublic FDA data

Miconazole 7

Product NDC
61269-730
11-digit product format
612690730
Labeler code
61269
Product ID
61269-730_03eea790-4814-4dd3-8cbf-20a3bc96ea0d
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
H2-Pharma, LLC
Application
ANDA074164
Marketing category
ANDA
Marketing start
2021-04-12
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
61269-730-41Miconazole 745 g in 1 TUBE, WITH APPLICATORCREAM452
61269-730-41Miconazole 71 in 1 CARTONCREAM12
61269-730-63Miconazole 71 in 1 CARTONCREAM12
61269-730-63Miconazole 745 g in 1 TUBE, WITH APPLICATORCREAM452

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-730-41GM - Gram61269-730c08120f8-57b4-41e7-b73b-aebd8fac5f5c12021-05-05
61269-730-63GM - Gram61269-730f361e5bb-302a-4a82-818f-5ac9991e1ac812021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-730MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [H2-PHARMA, LLC]2Current NDC, Legacy NDC, 2 package rows20230118_4bf1a555-a24f-4807-ac13-db19c55cf280.zip
61269-730MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [H2-PHARMA, LLC]2Current NDC, Legacy NDC, 2 package rows20230118_67dc7d38-a663-48d5-9abf-b3bd8dc0eddf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSN99c66cbd-7063-4b4c-b827-4f2fcb6ed67f5
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD99c66cbd-7063-4b4c-b827-4f2fcb6ed67f5
998540miconazole nitrate 2 % Vaginal CreamSY99c66cbd-7063-4b4c-b827-4f2fcb6ed67f5
998540miconazole nitrate 2 % Vaginal CreamPSN0c055a0d-1031-e7d5-e063-6294a90a17e22
998540miconazole nitrate 2 % Vaginal CreamPSN4bf1a555-a24f-4807-ac13-db19c55cf2802
998540miconazole nitrate 2 % Vaginal CreamPSN67dc7d38-a663-48d5-9abf-b3bd8dc0eddf2
998540miconazole nitrate 2 % Vaginal CreamPSNc33f7d75-d976-7f46-e053-2a95a90a98ec2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD0c055a0d-1031-e7d5-e063-6294a90a17e22
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD4bf1a555-a24f-4807-ac13-db19c55cf2802
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD67dc7d38-a663-48d5-9abf-b3bd8dc0eddf2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDc33f7d75-d976-7f46-e053-2a95a90a98ec2
998540miconazole nitrate 2 % Vaginal CreamSY0c055a0d-1031-e7d5-e063-6294a90a17e22
998540miconazole nitrate 2 % Vaginal CreamSY4bf1a555-a24f-4807-ac13-db19c55cf2802
998540miconazole nitrate 2 % Vaginal CreamSY67dc7d38-a663-48d5-9abf-b3bd8dc0eddf2
998540miconazole nitrate 2 % Vaginal CreamSYc33f7d75-d976-7f46-e053-2a95a90a98ec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61269-730-41612690730411 TUBE, WITH APPLICATOR in 1 CARTON (61269-730-41) / 45 g in 1 TUBE, WITH APPLICATOR2021-04-120000-00-00NoNoCurrent
61269-730-63612690730631 TUBE, WITH APPLICATOR in 1 CARTON (61269-730-63) / 45 g in 1 TUBE, WITH APPLICATOR2021-03-150000-00-00NoNoCurrent