VAGISTAT 3

Product NDC: 11509-0081
11-digit product format: 115090081
Labeler code: 11509
Product ID: 11509-0081_9181ac4a-a921-4c23-a199-eb62910b33f5
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole nitrate
Dosage form: KIT
Labeler: Combe Incorporated
Application: ANDA075329
Marketing category: ANDA
Marketing start: 2018-03-27
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A075329-001	MICONAZOLE NITRATE COMBINATION PACK	MICONAZOLE NITRATE	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL			1999-04-20

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	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: VAGISTAT 3
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992765	Internal RxNorm lookup
992766	Internal RxNorm lookup
992791	Internal RxNorm lookup
992792	Internal RxNorm lookup
998540	Internal RxNorm lookup
1359442	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
e15a28cd-9e64-4e9e-8df9-829d84f1816c	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
11509-0081-1	VAGISTAT 3	1 in 1 CARTON	KIT	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11509-0081-1	EA - Each	11509-0081	5a7d0ca1-e852-4798-a695-a980af9e4ae3	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11509-0081	VAGISTAT 3 (MICONAZOLE NITRATE) KIT [COMBE INCORPORATED]	5	Current NDC, Legacy NDC, 1 package rows	20250507_e15a28cd-9e64-4e9e-8df9-829d84f1816c.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
miconazole 3	MICONAZOLE NITRATE	Kroger Company	063153cc-00fd-4390-bc68-90b21203678a	2026-02-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
dg health miconazole 3	MICONAZOLE NITRATE	Dolgencorp Inc	d84aa78d-b408-4d51-a54c-c66f6cef33f1	2025-11-01	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Miconazole 3	MICONAZOLE NITRATE	Safeway	b32aec61-32c0-4c7f-b843-348243332583	2025-11-01	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
VAGISTAT 3	MICONAZOLE NITRATE	Combe Incorporated	e15a28cd-9e64-4e9e-8df9-829d84f1816c	2025-11-01	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329 ndc (product): 11509-0081
miconazole 3	MICONAZOLE NITRATE	H E B	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	2025-10-31	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
CareOne Miconazole 3	MICONAZOLE NITRATE	American Sales Company	84c43793-98e4-4e68-a3bc-3e7222135568	2025-10-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Miconazole 3	MICONAZOLE NITRATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	689ad530-48f9-4044-baa3-4f8b0657aeef	2025-10-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Equate Miconazole 3	MICONAZOLE NITRATE	WALMART INC.	5ade4c65-5757-4f20-b5be-f95d86363d11	2025-09-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Equaline Miconazole 3	MICONAZOLE NITRATE	United Natural Foods, Inc. dba UNFI	89328324-72d9-4b3d-bec7-cc2e4e62f034	2025-09-18	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
miconazole 3 day	MICONAZOLE NITRATE	Publix Super Markets Inc	9ff23f06-e97f-46ad-8601-97ca05c260a0	2025-09-16	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
topcare miconazole 3 combination pack	MICONAZOLE NITRATE	Topco Associates LLC	0af4c06a-aa79-48ab-9857-e0f56317d8f3	2025-09-16	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
miconazole 3	MICONAZOLE NITRATE	Meijer Distribution Inc	feaa0d07-013e-433f-8db4-550dc9ff737e	2025-09-11	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Foster and Thrive Miconazole 3	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	ba5d5b13-5604-4b8c-92b9-9f4174458029	2025-08-12	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Good Neighbor Pharmacy Miconazole 3	MICONAZOLE NITRATE	Amerisource Bergen	5b87b837-3f52-40ca-b2b6-9c1f1262d90d	2025-06-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Good Sense Miconazole 3	MICONAZOLE NITRATE	L. Perrigo Company	9aeac709-001b-4617-8046-186264847ec8	2025-05-15	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
miconazole 3	MICONAZOLE NITRATE	Rite Aid Corporation	4abee369-e8c5-4971-9545-8c015ff6eaad	2023-11-08	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Signature Care Miconazole 3	MICONAZOLE NITRATE	Safeway	191e448b-0410-4102-82ae-a3387b27b227	2021-02-04	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329

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
992792	{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Vagistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Vagistat]) } Pack [Vagistat 3 Day Combination Pack]	BPCK	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
992766	{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } Pack	GPCK	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
998540	miconazole nitrate 2 % Vaginal Cream	PSN	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
992765	miconazole nitrate 200 MG Vaginal Insert	PSN	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
992766	miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) Pack	PSN	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
1359442	Vagistat 2 % Vaginal Cream	PSN	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
992792	Vagistat 3 Combination Pack	PSN	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
992791	Vagistat-3 200 MG Vaginal Insert	PSN	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
1359442	miconazole nitrate 20 MG/ML Vaginal Cream [Vagistat]	SBD	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
992791	miconazole nitrate 200 MG Vaginal Insert [Vagistat]	SBD	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
992765	miconazole nitrate 200 MG Vaginal Insert	SCD	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
992766	miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)	SY	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
992766	miconazole 3 Day Vaginal Insert Combination Pack	SY	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
998540	miconazole nitrate 2 % Vaginal Cream	SY	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
1359442	Vagistat 2 % Vaginal Cream	SY	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
992791	Vagistat 200 MG Vaginal Insert	SY	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
992792	Vagistat 3 Combination Pack	SY	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
1359442	Vagistat-3 2 % Vaginal Cream	SY	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6
992791	Vagistat-3 200 MG Vaginal Insert	SY	e15a28cd-9e64-4e9e-8df9-829d84f1816c	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11509-0081-1	11509008101	1 KIT in 1 CARTON (11509-0081-1) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE	1 kit	2018-03-27	0000-00-00	No	No	Current