Home NDC 50090-4356 Miconazole Nitrate
Product NDC 50090-4356
11-digit product format 500904356
Labeler code 50090
Product ID 50090-4356_e0ebd43f-a346-46cc-be47-7f4de5dff3e9
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route VAGINAL
Labeler A-S Medication Solutions
Application ANDA074444
Marketing category ANDA
Marketing start 1997-01-13
Substance MICONAZOLE NITRATE
Active strength 20 mg/g
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 42 .
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 A074444-001 MICONAZOLE NITRATE MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13
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 · 42 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 2026-08-18 06:07:40 2026-07 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Miconazole Nitrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 20 mg/g
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 50090-4356-0 Miconazole Nitrate 45 g in 1 TUBE, WITH APPLICATOR CREAM 45 9 50090-4356-0 Miconazole Nitrate 1 in 1 CARTON CREAM 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4356 MICONAZOLE NITRATE CREAM [A-S MEDICATION SOLUTIONS] 7 Current NDC, Legacy NDC, 2 package rows 20231216_a32fc37b-bcad-4f56-8dc6-cf36a6716196.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-4356-0 50090435600 1 TUBE, WITH APPLICATOR in 1 CARTON (50090-4356-0) / 45 g in 1 TUBE, WITH APPLICATOR 2019-06-14 0000-00-00 No No Current