ORAVIG

Product NDC: 89141-250
11-digit product format: 891410250
Labeler code: 89141
Product ID: 89141-250_cb8158af-88fd-4c9f-8daf-0de630d62af9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: miconazole
Dosage form: TABLET
Route: BUCCAL
Labeler: Midatech Pharma US, Inc.
Application: NDA022404
Marketing category: NDA
Marketing start: 2010-04-16
Marketing end: 0000-00-00
Substance: MICONAZOLE
Active strength: 50 mg/1
Pharmacologic classes: Azole Antifungal [EPC],Azoles [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	89141-250		D	Discontinued by firm	2026-08-03
excluded package	package	89141-250	89141-250-02	D	Discontinued by firm	2026-08-03
excluded package	package	89141-250	89141-250-14	D	Discontinued by firm	2026-08-03

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	89141-250-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	89141-250-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	89141-250-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	89141-250-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	89141-250-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	89141-250-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	89141-250-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	89141-250-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	89141-250-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	89141-250-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	89141-250-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	89141-250-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	89141-250-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	89141-250-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	89141-250-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	89141-250-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	89141-250-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	89141-250-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	89141-250-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	89141-250-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	89141-250-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	89141-250-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	89141-250-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	89141-250-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
89141-250-02	2022-02-04	These highlights do not include all the information needed to use ORAVIG safely and effectively. See full prescribing information for ORAVIG. ORAVIG (miconazole) buccal tablets Initial U.S. Approval: January 1974
89141-250-14	2022-02-04	These highlights do not include all the information needed to use ORAVIG safely and effectively. See full prescribing information for ORAVIG. ORAVIG (miconazole) buccal tablets Initial U.S. Approval: January 1974
89141-250-02	2022-01-28	These highlights do not include all the information needed to use ORAVIG safely and effectively. See full prescribing information for ORAVIG. ORAVIG (miconazole) buccal tablets Initial U.S. Approval: January 1974
89141-250-14	2022-01-28	These highlights do not include all the information needed to use ORAVIG safely and effectively. See full prescribing information for ORAVIG. ORAVIG (miconazole) buccal tablets Initial U.S. Approval: January 1974

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
89141-250-14	EA - Each	89141-250	4b9ac87e-4ed0-449c-8345-a434ae601088	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MICONAZOLE	ACTIVE INGREDIENT	7NNO0D7S5M	ORAVIG (MICONAZOLE) TABLET [DARA BIOSCIENCES, INC.]	1
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	ORAVIG (MICONAZOLE) TABLET [DARA BIOSCIENCES, INC.]	1
CASEIN	INACTIVE INGREDIENT	48268V50D5	ORAVIG (MICONAZOLE) TABLET [DARA BIOSCIENCES, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORAVIG (MICONAZOLE) TABLET [DARA BIOSCIENCES, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORAVIG (MICONAZOLE) TABLET [DARA BIOSCIENCES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORAVIG (MICONAZOLE) TABLET [DARA BIOSCIENCES, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ORAVIG (MICONAZOLE) TABLET [DARA BIOSCIENCES, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ORAVIG (MICONAZOLE) TABLET [DARA BIOSCIENCES, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ORAVIG (MICONAZOLE) TABLET [DARA BIOSCIENCES, INC.]	1

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oravig	MICONAZOLE	Galt Pharmaceuticals, LLC	dc2427ff-e566-4b48-b289-9e51c011250a	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022404 application number: NDA022404

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7NNO0D7S5M	MICONAZOLE	22916-47-8	MICONAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
89141-250-02	89141025002	1 BOTTLE in 1 CARTON (89141-250-02) > 2 TABLET in 1 BOTTLE	1 bottle	2015-10-15	0000-00-00	No	No	Current
89141-250-14	89141025014	1 BOTTLE in 1 CARTON (89141-250-14) > 14 TABLET in 1 BOTTLE	1 bottle	2015-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ORAVIG	Midatech Pharma US, Inc. \| Catalent Germany Schorndorf GmbH \| Olon SpA \| KEYBIO \| CEBIPHAR	2020-02-12	HUMAN PRESCRIPTION DRUG LABEL	6