Home NDC 49348-355 sunmark miconazole 3
Product NDC 49348-355
11-digit product format 493480355
Labeler code 49348
Product ID 49348-355_b0fa9f9d-9a31-41f6-8cdf-575818147fc5
Type HUMAN OTC DRUG
Nonproprietary name Miconazole nitrate
Dosage form KIT
Labeler Strategic Sourcing Services LLC
Application ANDA075329
Marketing category ANDA
Marketing start 2003-09-05
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49348-355 SUNMARK MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [STRATEGIC SOURCING SERVICES LLC] 6 Legacy NDC 20241225_e00db934-75b4-4044-913d-156e96fc142f.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49348-355-43 49348035543 1 KIT in 1 CARTON (49348-355-43) * 3 BLISTER PACK in 1 KIT > 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT > 9 g in 1 TUBE 1 kit 2003-09-05 0000-00-00 No No Current