Home NDC 36800-081 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075329-001 MICONAZOLE NITRATE COMBINATION PACK MICONAZOLE NITRATE 2%,200MG CREAM, SUPPOSITORY / TOPICAL, VAGINAL 1999-04-20
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A075329-001 MICONAZOLE NITRATE COMBINATION PACK 2%,200MG CREAM, SUPPOSITORY / TOPICAL, VAGINAL 1999-04-20 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 17 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base topcare miconazole 3
Brand name suffix combination pack
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992765 Internal RxNorm lookup 992766 Internal RxNorm lookup 998540 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-081-00 topcare miconazole 3combination pack 1 in 1 CARTON KIT 1 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-081 TOPCARE MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC] 5 Current NDC, Legacy NDC, 1 package rows 20210220_0af4c06a-aa79-48ab-9857-e0f56317d8f3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-081-00 36800008100 1 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 TUBE 1 kit 2000-05-10 0000-00-00 No No Current