Home NDC 36800-070-09 TopCare
Product NDC 36800-070
Requested package NDC 36800-070-09
11-digit product format 368000070
Labeler code 36800
Product ID 36800-070_b523b32b-f4d0-446a-8344-bdf52e578d71
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route VAGINAL
Labeler Topco Associates LLC
Application ANDA076773
Marketing category ANDA
Marketing start 2005-03-02
Marketing end 0000-00-00
Substance MICONAZOLE NITRATE
Active strength 40 mg/g
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-070-09 TopCare Miconazole 3 Yeast Infection Relief 1 in 1 CARTON CREAM 1 2 36800-070-09 TopCare Miconazole 3 Yeast Infection Relief 25 g in 1 TUBE, WITH APPLICATOR CREAM 25 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-070 TOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC] 2 Legacy NDC, 2 package rows 20191106_d6f3e419-45f2-4acc-9c14-daead374aa72.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 36800-070-09 36800007009 1 TUBE, WITH APPLICATOR in 1 CARTON (36800-070-09) > 25 g in 1 TUBE, WITH APPLICATOR 2013-01-16 0000-00-00 No No Current