Miconazole 3 Combination Pack

Product NDC: 59779-773
11-digit product format: 597790773
Labeler code: 59779
Product ID: 59779-773_a19a2156-8c0e-4381-8599-1a5557569a9a
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: KIT
Labeler: CVS Pharmacy
Application: ANDA074926
Marketing category: ANDA
Marketing start: 2001-03-01
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	59779-773	59779-773-03	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 · 12 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…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Miconazole 3 Combination Pack
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992765	Internal RxNorm lookup
992766	Internal RxNorm lookup
998540	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
65c99592-7c11-41fc-8296-aad0a8f39926	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59779-773-03	Miconazole 3 Combination Pack	1 in 1 PACKAGE, COMBINATION	KIT	1		8
59779-773-43	Miconazole 3 Combination Pack	1 in 1 PACKAGE, COMBINATION	KIT	1		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	1
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	1
HYDROGENATED PALM KERNEL OIL	INACTIVE INGREDIENT	FM8D1RE2VP	MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	1
PEG-5 OLEATE	INACTIVE INGREDIENT	0240V77G50	MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	1
PEGOXOL 7 STEARATE	INACTIVE INGREDIENT	3EW5AXE5X5	MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-773	MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	8	Current NDC, Legacy NDC, 2 package rows	20230119_65c99592-7c11-41fc-8296-aad0a8f39926.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 · 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 ndc (product): 59779-773

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VW4H1CYW1K	MICONAZOLE NITRATE	22832-87-7	Miconazole Nitrate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
992766	{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } Pack	GPCK	65c99592-7c11-41fc-8296-aad0a8f39926	8
998540	miconazole nitrate 2 % Vaginal Cream	PSN	65c99592-7c11-41fc-8296-aad0a8f39926	8
992765	miconazole nitrate 200 MG Vaginal Insert	PSN	65c99592-7c11-41fc-8296-aad0a8f39926	8
992766	miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) Pack	PSN	65c99592-7c11-41fc-8296-aad0a8f39926	8
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	65c99592-7c11-41fc-8296-aad0a8f39926	8
992765	miconazole nitrate 200 MG Vaginal Insert	SCD	65c99592-7c11-41fc-8296-aad0a8f39926	8
992766	miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)	SY	65c99592-7c11-41fc-8296-aad0a8f39926	8
992766	miconazole 3 Day Vaginal Insert Combination Pack	SY	65c99592-7c11-41fc-8296-aad0a8f39926	8
998540	miconazole nitrate 2 % Vaginal Cream	SY	65c99592-7c11-41fc-8296-aad0a8f39926	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-773-03	59779077303	1 in 1 PACKAGE, COMBINATION						Historical
59779-773-43	59779077343	1 KIT in 1 PACKAGE, COMBINATION (59779-773-43) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE	1 kit	2001-03-01	0000-00-00	No	No	Current