careone miconazole 1

Product NDC
41520-616
11-digit product format
415200616
Labeler code
41520
Product ID
41520-616_23802cdc-7a89-4009-af85-8ad1f1a3046d
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
American Sales Company
Application
ANDA079114
Marketing category
ANDA
Marketing start
2020-01-15
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
careone miconazole 1
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992774, 992775, 998483, 998540

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-616-002023-11-01C16284748780-1f386c649-abec-0266-e053-dadaa90a7c1aAmerican Sales Company Miconazole 1 Drug Facts
41520-616-002023-01-30C16284748780-1f386c649-abec-0266-e053-dadaa90a7c1aAmerican Sales Company Miconazole 1 Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-616-00careone miconazole 11 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-616CAREONE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [AMERICAN SALES COMPANY]3Current NDC, Legacy NDC, 1 package rows20231101_f51af8e2-fb06-4842-8021-b7efd515022e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992775{1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } PackGPCKf51af8e2-fb06-4842-8021-b7efd515022e3
992775miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) PackPSNf51af8e2-fb06-4842-8021-b7efd515022e3
992774miconazole nitrate 1200 MG Vaginal InsertPSNf51af8e2-fb06-4842-8021-b7efd515022e3
998483miconazole nitrate 2 % Topical CreamPSNf51af8e2-fb06-4842-8021-b7efd515022e3
998540miconazole nitrate 2 % Vaginal CreamPSNf51af8e2-fb06-4842-8021-b7efd515022e3
992774miconazole nitrate 1200 MG Vaginal InsertSCDf51af8e2-fb06-4842-8021-b7efd515022e3
998483miconazole nitrate 20 MG/ML Topical CreamSCDf51af8e2-fb06-4842-8021-b7efd515022e3
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDf51af8e2-fb06-4842-8021-b7efd515022e3
992774miconazole nitrate 1.2 GM Vaginal InsertSYf51af8e2-fb06-4842-8021-b7efd515022e3
998483miconazole nitrate 2 % Topical CreamSYf51af8e2-fb06-4842-8021-b7efd515022e3
998540miconazole nitrate 2 % Vaginal CreamSYf51af8e2-fb06-4842-8021-b7efd515022e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-616-00415200616001 KIT in 1 CARTON (41520-616-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE1 kit2020-01-150000-00-00NoNoCurrent