Home NDC 41250-825 Miconazole 7
Product NDC 41250-825
11-digit product format 412500825
Labeler code 41250
Product ID 41250-825_a5a79dd8-fe53-4dac-a3ae-1f73be8135a9
Type HUMAN OTC DRUG
Nonproprietary name Miconazole nitrate
Dosage form CREAM
Route VAGINAL
Labeler Meijer Distribution Inc
Application ANDA074760
Marketing category ANDA
Marketing start 2000-02-04
Substance MICONAZOLE NITRATE
Active strength 2 g/100g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 A074760-001 MICONAZOLE NITRATE MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Miconazole 7
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VW4H1CYW1K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 41250-825-29 Miconazole 7 1 in 1 CARTON CREAM 1 7 41250-825-29 Miconazole 7 45 g in 1 TUBE CREAM 45 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41250-825 MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [MEIJER DISTRIBUTION INC] 5 Current NDC, Legacy NDC, 2 package rows 20210106_b8417956-4c53-444e-823a-a87748eb0a08.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 19 matching rows.
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 41250-825-29 41250082529 1 TUBE in 1 CARTON (41250-825-29) / 45 g in 1 TUBE 1 tube 2000-02-04 0000-00-00 No No Current