Home NDC 61825-303 Oravig
Product NDC 61825-303
11-digit product format 618250303
Labeler code 61825
Product ID 61825-303_47da8a7f-0d47-f1cd-e063-6394a90a84ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Miconazole
Dosage form TABLET
Route BUCCAL
Labeler Galt Pharmaceuticals, LLC
Application NDA022404
Marketing category NDA
Marketing start 2021-12-31
Substance MICONAZOLE
Active strength 50 mg/1
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 N022404-001 ORAVIG MICONAZOLE 50MG TABLET / BUCCAL RLD, RS 2010-04-16
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 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD 2010-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD 2010-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 54 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022404-001 6916485 2022-09-11 U-1051 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022404-001 7651698 2022-09-11 U-1051 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022404-001 6916485 2022-09-11 U-1051 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022404-001 7651698 2022-09-11 U-1051 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022404-001 6916485 2022-09-11 U-1051 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022404-001 7651698 2022-09-11 U-1051 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022404-001 6916485 2022-09-11 U-1051 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022404-001 7651698 2022-09-11 U-1051 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022404-001 6916485 2022-09-11 U-1051 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022404-001 7651698 2022-09-11 U-1051 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022404-001 6916485 2022-09-11 U-1051 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022404-001 7651698 2022-09-11 U-1051 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022404-001 6916485 2022-09-11 U-1051 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022404-001 7651698 2022-09-11 U-1051 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022404-001 6916485 2022-09-11 U-1051 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022404-001 7651698 2022-09-11 U-1051 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022404-001 6916485 2022-09-11 U-1051 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022404-001 7651698 2022-09-11 U-1051 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022404-001 6916485 2022-09-11 U-1051 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022404-001 7651698 2022-09-11 U-1051 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022404-001 6916485 2022-09-11 U-1051 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022404-001 7651698 2022-09-11 U-1051 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022404-001 6916485 2022-09-11 U-1051 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022404-001 7651698 2022-09-11 U-1051 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022404-001 6916485 2022-09-11 U-1051 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022404-001 7651698 2022-09-11 U-1051 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 ea99ee380514…2023-01-26 05:58 UTC 2023-01 N022404-001 6916485 2022-09-11 U-1051 Drug product 3bdfa0b2c4d7…
Additional Listing Data#
Finished product Yes
Brand name base Oravig
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7NNO0D7S5M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998548 Internal RxNorm lookup 998550 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 61825-303-14 Oravig 14 in 1 BOTTLE TABLET 14 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61825-303 ORAVIG (MICONAZOLE) TABLET [GALT PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20240110_dc2427ff-e566-4b48-b289-9e51c011250a.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 61825-303-14 61825030314 14 TABLET in 1 BOTTLE (61825-303-14) 14 tablet 2021-12-31 0000-00-00 No No Current