Miconazole Nitrate

Product NDC
70677-1000
11-digit product format
706771000
Labeler code
70677
Product ID
70677-1000_39fae2a4-9033-3c88-e063-6394a90acbd5
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
STRATEGIC SOURCING SERVICES LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-14
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 Nitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998483

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
70677-1000-1Miconazole Nitrate1 in 1 CARTONCREAM13
70677-1000-1Miconazole Nitrate30 g in 1 TUBECREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1000MICONAZOLE NITRATE CREAM [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 2 package rows20241109_966a1000-3b08-4f2c-a9f8-568f2524b717.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN966a1000-3b08-4f2c-a9f8-568f2524b7173
998483miconazole nitrate 20 MG/ML Topical CreamSCD966a1000-3b08-4f2c-a9f8-568f2524b7173
998483miconazole nitrate 2 % Topical CreamSY966a1000-3b08-4f2c-a9f8-568f2524b7173

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1000-1706771000011 TUBE in 1 CARTON (70677-1000-1) / 30 g in 1 TUBE1 tube2023-07-14NoNoCurrent