topcare miconazole 3

Product NDC
36800-081
11-digit product format
368000081
Labeler code
36800
Product ID
36800-081_28b14543-3ba9-4c9c-a9bd-a94d1ca3bc90
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Topco Associates LLC
Application
ANDA075329
Marketing category
ANDA
Marketing start
2000-05-10
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 3
Brand name suffix
combination pack
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992765, 992766, 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
36800-081-00topcare miconazole 3combination pack1 in 1 CARTONKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-081-00EA - Each36800-0813d2dfbd4-4f5a-47eb-bdc3-03359f7281af12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-081TOPCARE MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 1 package rows20210220_0af4c06a-aa79-48ab-9857-e0f56317d8f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992766{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } PackGPCK0af4c06a-aa79-48ab-9857-e0f56317d8f36
998540miconazole nitrate 2 % Vaginal CreamPSN0af4c06a-aa79-48ab-9857-e0f56317d8f36
992765miconazole nitrate 200 MG Vaginal InsertPSN0af4c06a-aa79-48ab-9857-e0f56317d8f36
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSN0af4c06a-aa79-48ab-9857-e0f56317d8f36
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD0af4c06a-aa79-48ab-9857-e0f56317d8f36
992765miconazole nitrate 200 MG Vaginal InsertSCD0af4c06a-aa79-48ab-9857-e0f56317d8f36
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SY0af4c06a-aa79-48ab-9857-e0f56317d8f36
992766miconazole 3 Day Vaginal Insert Combination PackSY0af4c06a-aa79-48ab-9857-e0f56317d8f36
998540miconazole nitrate 2 % Vaginal CreamSY0af4c06a-aa79-48ab-9857-e0f56317d8f36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-081-00368000081001 KIT in 1 CARTON (36800-081-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE1 kit2000-05-100000-00-00NoNoCurrent