topcare miconazole 1

Product NDC
36800-199
11-digit product format
368000199
Labeler code
36800
Product ID
36800-199_aae0dcb7-6128-4681-b2c0-12be5aff38a1
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Topco Associates LLC
Application
ANDA079114
Marketing category
ANDA
Marketing start
2010-06-17
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
topcare 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-199-00topcare miconazole 11 in 1 CARTONKIT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-199-00EA - Each36800-19969e80fea-1bee-42d9-aca0-4b5491a8f1e012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2
MICONAZOLEACTIVE MOIETY7NNO0D7S5MTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2
GELATININACTIVE INGREDIENT2G86QN327LTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-199TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]8Current NDC, Legacy NDC, 1 package rows20241219_8138de63-c7e9-4b2c-a0e2-c62292a0b320.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) } PackGPCK8138de63-c7e9-4b2c-a0e2-c62292a0b3208
992775miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) PackPSN8138de63-c7e9-4b2c-a0e2-c62292a0b3208
992774miconazole nitrate 1200 MG Vaginal InsertPSN8138de63-c7e9-4b2c-a0e2-c62292a0b3208
998483miconazole nitrate 2 % Topical CreamPSN8138de63-c7e9-4b2c-a0e2-c62292a0b3208
998540miconazole nitrate 2 % Vaginal CreamPSN8138de63-c7e9-4b2c-a0e2-c62292a0b3208
992774miconazole nitrate 1200 MG Vaginal InsertSCD8138de63-c7e9-4b2c-a0e2-c62292a0b3208
998483miconazole nitrate 20 MG/ML Topical CreamSCD8138de63-c7e9-4b2c-a0e2-c62292a0b3208
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD8138de63-c7e9-4b2c-a0e2-c62292a0b3208
992774miconazole nitrate 1.2 GM Vaginal InsertSY8138de63-c7e9-4b2c-a0e2-c62292a0b3208
998483miconazole nitrate 2 % Topical CreamSY8138de63-c7e9-4b2c-a0e2-c62292a0b3208
998540miconazole nitrate 2 % Vaginal CreamSY8138de63-c7e9-4b2c-a0e2-c62292a0b3208

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-199-00368000199001 KIT in 1 CARTON (36800-199-00) * 1 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE1 kit2010-06-170000-00-00NoNoCurrent