Home NDC 0363-0081 Miconazole 3
Product NDC 0363-0081
11-digit product format 003630081
Labeler code 0363
Product ID 0363-0081_1cebdec6-3529-41da-9e9d-3c727993c525
Type HUMAN OTC DRUG
Nonproprietary name Miconazole nitrate
Dosage form KIT
Labeler Walgreen Company
Application ANDA075329
Marketing category ANDA
Marketing start 2005-07-01
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-0081-00 Miconazole 3 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 0363-0081 MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [WALGREEN COMPANY] 6 Current NDC, Legacy NDC, 1 package rows 20220818_3fb97e73-a088-472b-928e-1807fa822e1b.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 0363-0081-00 00363008100 1 KIT in 1 CARTON (0363-0081-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE 1 kit 2005-07-01 0000-00-00 No No Current