Home NDC 51672-2070 Miconazole Nitrate
Product NDC 51672-2070
11-digit product format 516722070
Labeler code 51672
Product ID 51672-2070_38e566b7-9252-2731-e063-6294a90ad263
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route VAGINAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA076773
Marketing category ANDA
Marketing start 2005-03-02
Substance MICONAZOLE NITRATE
Active strength 40 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
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 A076773-001 MICONAZOLE 3 MICONAZOLE NITRATE 4% CREAM / VAGINAL 2005-03-02
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 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076773-001 MICONAZOLE 3 4% CREAM / VAGINAL 2005-03-02 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Miconazole Nitrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 40 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 998544 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 51672-2070-9 Miconazole Nitrate 25 g in 1 TUBE, WITH APPLICATOR CREAM 25 5 51672-2070-9 Miconazole Nitrate 1 in 1 CARTON CREAM 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Miconazole Nitrate ACTIVE INGREDIENT VW4H1CYW1K MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 Miconazole ACTIVE MOIETY 7NNO0D7S5M MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 isopropyl myristate INACTIVE INGREDIENT 0RE8K4LNJS MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 potassium hydroxide INACTIVE INGREDIENT WZH3C48M4T MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-2070 MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240524_eaca3e39-6ea0-4d7e-803c-db22024ad9f9.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 · 3 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 51672-2070-9 51672207009 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2070-9) / 25 g in 1 TUBE, WITH APPLICATOR 2005-03-02 0000-00-00 No No Current