Leader Miconazole 3

Product NDC: 70000-0669
Requested package NDC: 70000-0669-1
11-digit product format: 700000669
Labeler code: 70000
Product ID: 70000-0669_1c6314df-4429-4d58-bdc2-12830d55f036
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole nitrate
Dosage form: KIT
Labeler: Cardinal Health 110, LLC. dba Leader
Application: ANDA076357
Marketing category: ANDA
Marketing start: 2024-06-27
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 43.

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
A076357-001	MICONAZOLE 3 COMBINATION PACK	MICONAZOLE NITRATE	2%,4%	CREAM / TOPICAL, VAGINAL			2004-03-30

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Leader Miconazole 3
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
992816	Internal RxNorm lookup
998540	Internal RxNorm lookup
998544	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
7f6df893-f404-4b2d-ab2b-696c8a2d36fa	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
0113-7198-00	Leader Miconazole 3	5 g in 1 APPLICATOR	CREAM	15 g	4 g in 100g	2
0113-7198-00	Leader Miconazole 3	1 in 1 POUCH	CREAM		4 g in 100g	2
0113-8123-00	Leader Miconazole 3	1 in 1 CARTON	CREAM		2 g in 100g	2
0113-8123-00	Leader Miconazole 3	9 g in 1 TUBE	CREAM	9 g	2 g in 100g	2
70000-0669-1	Leader Miconazole 3	1 in 1 CARTON	KIT	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0669	LEADER MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CARDINAL HEALTH 110, LLC. DBA LEADER]	1	Current NDC, 5 package rows	20240711_7f6df893-f404-4b2d-ab2b-696c8a2d36fa.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole 3	MICONAZOLE NITRATE	Rite Aid Corporation	78b6ac87-3de0-44e9-9e28-b4c7ab028fd5	2026-07-07	Warnings	Exact identifier application applno (ANDA): 076357 application number: ANDA076357
Miconazole 3	MICONAZOLE NITRATE	Meijer Distribution Inc	c915a495-8eac-4a1a-83a4-c874682433c8	2026-05-07	Warnings	Exact identifier application applno (ANDA): 076357 application number: ANDA076357
Rugby Miconazole 3	MICONAZOLE NITRATE	Rugby Laboratories	2d7035fa-9695-4d66-89f5-bd26420450ef	2026-02-25	Warnings	Exact identifier application applno (ANDA): 076357 application number: ANDA076357
Up and Up Miconazole 3	MICONAZOLE NITRATE	Target Corporation	9a186532-ee69-428e-98a9-8ee69f4d667a	2026-01-30	Warnings	Exact identifier application applno (ANDA): 076357 application number: ANDA076357
foster and thrive miconazole 3	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	4c536e07-5e88-4bdd-a5b2-10226d5486ed	2025-12-16	Warnings	Exact identifier application applno (ANDA): 076357 application number: ANDA076357
Leader Miconazole 3	MICONAZOLE NITRATE	Cardinal Health 110, LLC. dba Leader	7f6df893-f404-4b2d-ab2b-696c8a2d36fa	2025-09-29	Warnings	Exact identifier application applno (ANDA): 076357 application number: ANDA076357 ndc (package): 70000-0669-1 ndc (product): 70000-0669 ndc11 (package): 70000066901
Miconazole 3	MICONAZOLE NITRATE	CVS Pharmacy	9f506f59-e435-465d-90c7-9b0edc44160d	2025-04-24	Warnings	Exact identifier application applno (ANDA): 076357 application number: ANDA076357

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
992816	{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream) } Pack	GPCK	7f6df893-f404-4b2d-ab2b-696c8a2d36fa	2
992816	miconazole 3 Day - (4 % applicator 5 GM / 2 % cream 9 GM) Pack	PSN	7f6df893-f404-4b2d-ab2b-696c8a2d36fa	2
998540	miconazole nitrate 2 % Vaginal Cream	PSN	7f6df893-f404-4b2d-ab2b-696c8a2d36fa	2
998544	miconazole nitrate 4 % Vaginal Cream	PSN	7f6df893-f404-4b2d-ab2b-696c8a2d36fa	2
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	7f6df893-f404-4b2d-ab2b-696c8a2d36fa	2
998544	miconazole nitrate 40 MG/ML Vaginal Cream	SCD	7f6df893-f404-4b2d-ab2b-696c8a2d36fa	2
992816	{3 (5 GM miconazole nitrate 200 MG (4 % ) Prefilled Applicator) / 1 (9 GM miconazole nitrate 2 % Vaginal Cream) } Pack	SY	7f6df893-f404-4b2d-ab2b-696c8a2d36fa	2
992816	{3 (5000 MG miconazole nitrate 4 % Prefilled Applicator) / 1 (0.32 OZ miconazole nitrate 2 % Vaginal Cream) } Pack	SY	7f6df893-f404-4b2d-ab2b-696c8a2d36fa	2
992816	Miconazole 3 Day Prefilled Applicator Combination Pack	SY	7f6df893-f404-4b2d-ab2b-696c8a2d36fa	2
998540	miconazole nitrate 2 % Vaginal Cream	SY	7f6df893-f404-4b2d-ab2b-696c8a2d36fa	2
998544	miconazole nitrate 4 % Vaginal Cream	SY	7f6df893-f404-4b2d-ab2b-696c8a2d36fa	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70000-0669-1	70000066901	1 KIT in 1 CARTON (70000-0669-1) * 1 APPLICATOR in 1 POUCH (0113-7198-00) / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON (0113-8123-00) / 9 g in 1 TUBE	1 kit	2024-06-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cardinal Health Miconazole 3 Drug Facts	Cardinal Health 110, LLC. dba Leader	2025-09-29	HUMAN OTC DRUG LABEL	2