Home NDC 0472-1738 Miconazole Nitrate
Product NDC 0472-1738
11-digit product format 004721738
Labeler code 0472
Product ID 0472-1738_bb1aad58-4ca7-4be9-8649-0f29e22b81f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Miconazole Nitrate
Dosage form SUPPOSITORY
Route VAGINAL
Labeler Actavis Pharma, Inc.
Application ANDA073508
Marketing category ANDA
Marketing start 1995-01-18
Substance MICONAZOLE NITRATE
Active strength 200 mg/1
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 A073508-001 MICONAZOLE NITRATE MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073508-001 AB
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 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A073508-001 MICONAZOLE NITRATE 200MG SUPPOSITORY / VAGINAL AB 1993-11-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 200 mg/1
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 992765 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 0472-1738-03 Miconazole Nitrate 3 in 1 CARTON SUPPOSITORY 3 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0472-1738 MICONAZOLE NITRATE SUPPOSITORY [ACTAVIS PHARMA, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20201022_aa9e250b-f317-42cb-b8d2-e85de56f4ef7.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 · 1 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 0472-1738-03 00472173803 3 SUPPOSITORY in 1 CARTON (0472-1738-03) 3 suppository 1995-01-18 0000-00-00 No No Current