Miconazole 3 Combination Pack

Product NDC: 37205-583
Requested package NDC: 37205-583-03
11-digit product format: 372050583
Labeler code: 37205
Product ID: 37205-583_9949ea76-b979-4969-80dd-5f17d586638b
Type: HUMAN OTC DRUG
Nonproprietary name: miconazole nitrate
Dosage form: KIT
Route: VAGINAL
Labeler: Cardinal Health (Leader) 37205
Application: ANDA074926
Marketing category: ANDA
Marketing start: 2002-12-02
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	37205-583	37205-583-03	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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`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
A074926-001	M-ZOLE 3 COMBINATION PACK	MICONAZOLE NITRATE	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL			1999-04-16

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074926-001	M-ZOLE 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-16	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-583-03	EA - Each	37205-583	bfd3b2c8-ed4b-4ce4-82e1-7bad1b347a51	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CARDINAL HEALTH]	1
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CARDINAL HEALTH]	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole 3 Combination Pack	MICONAZOLE NITRATE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	50f2a26c-8203-4a10-8d0d-ad0f9fadb6bc	2025-09-08	Warnings	Exact identifier application applno (ANDA): 074926 application number: ANDA074926
Miconazole 3 Combination Pack	MICONAZOLE NITRATE	Chain Drug Consortium, LLC	d01f7ef9-4f04-4874-a625-0335f6392b73	2025-09-05	Warnings	Exact identifier application applno (ANDA): 074926 application number: ANDA074926
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit	MICONAZOLE NITRATE	Cosette Pharmaceuticals, Inc.	eed88487-a7ba-4853-8519-13f92ed5539f	2025-01-06	Warnings	Exact identifier application applno (ANDA): 074926 application number: ANDA074926
Miconazole 3 Combination Pack	MICONAZOLE NITRATE	CVS Pharmacy	65c99592-7c11-41fc-8296-aad0a8f39926	2023-01-18	Warnings	Exact identifier application applno (ANDA): 074926 application number: ANDA074926

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VW4H1CYW1K	MICONAZOLE NITRATE	22832-87-7	miconazole nitrate

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37205-583-03	37205058303	1 KIT in 1 PACKAGE, COMBINATION (37205-583-03) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE	1 kit	2002-12-02	0000-00-00	No	No	Current