Miconazole 7

Product NDC: 68071-2419
11-digit product format: 680712419
Labeler code: 68071
Product ID: 68071-2419_c33f87bb-ac60-88da-e053-2995a90a92e1
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: CREAM
Route: VAGINAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA074164
Marketing category: ANDA
Marketing start: 2021-04-12
Marketing end: 0000-00-00
Substance: MICONAZOLE NITRATE
Active strength: 20 mg/g
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-2419		I	Inactivated by FDA		2026-08-03
excluded package	package	68071-2419	68071-2419-7	I	Inactivated by FDA		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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2419-7	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2419-7	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2419-7	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2419-7	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2419-7	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2419-7	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2419-7	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2419-7	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2419-7	U	Excluded because listing certification expired	`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
A074164-001	MICONAZOLE 7	MICONAZOLE NITRATE	2%	CREAM / VAGINAL			1996-03-29

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	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2419-7	2025-01-30	C162847	48780-1	f386c649-d51f-0266-e053-dadaa90a7c1a	Miconazole 7
68071-2419-7	2023-10-05	C162847	48780-1	f386c649-d51f-0266-e053-dadaa90a7c1a	Miconazole 7
68071-2419-7	2023-01-30	C162847	48780-1	f386c649-d51f-0266-e053-dadaa90a7c1a	Miconazole 7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2419-7	Miconazole 7	1 in 1 CARTON	CREAM	1		2
68071-2419-7	Miconazole 7	45 g in 1 TUBE, WITH APPLICATOR	CREAM	45		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2419	MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [NUCARE PHARMACEUTICALS,INC.]	2	Legacy NDC, 2 package rows	20231006_c33f7d75-d976-7f46-e053-2a95a90a98ec.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole 7	MICONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	85a52081-d9cc-44f0-a8d3-851a45c4eb10	2026-07-08	Warnings	Exact identifier application applno (ANDA): 074164 application number: ANDA074164
Miconazole 7	MICONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	99c66cbd-7063-4b4c-b827-4f2fcb6ed67f	2026-07-08	Warnings	Exact identifier application applno (ANDA): 074164 application number: ANDA074164
Miconazole 7	MICONAZOLE NITRATE	Walgreens	0d991104-df96-49b8-b146-67f47b5fcd20	2026-06-16	Warnings	Exact identifier application applno (ANDA): 074164 application number: ANDA074164
Miconazole 7	MICONAZOLE NITRATE	Family Dollar (FAMILY WELLNESS)	c0249750-551a-4ab3-b5f1-409957889c8e	2026-03-16	Warnings	Exact identifier application applno (ANDA): 074164 application number: ANDA074164
Miconazole 7	MICONAZOLE NITRATE	NuCare Pharmaceuticals,Inc.	0c055a0d-1031-e7d5-e063-6294a90a17e2	2025-02-03	Warnings	Exact identifier application applno (ANDA): 074164 application number: ANDA074164
Miconazole 7	MICONAZOLE NITRATE	P & L Development, LLC	facc7b65-0376-445a-8a3d-5180f2f9d5ff	2024-11-05	Warnings	Exact identifier application applno (ANDA): 074164 application number: ANDA074164
Miconazole 7	MICONAZOLE NITRATE	Major Pharmaceuticals	825ac1c5-470e-4ee1-857d-b205c26fc634	2024-10-07	Warnings	Exact identifier application applno (ANDA): 074164 application number: ANDA074164
Miconazole 7	MICONAZOLE NITRATE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	0cef9212-201d-4fd2-8afb-ae06ea6b6ee4	2024-09-11	Warnings	Exact identifier application applno (ANDA): 074164 application number: ANDA074164
Miconazole 7	MICONAZOLE NITRATE	QUALITY CHOICE (Chain Drug Marketing Association)	84bef1d3-e4f8-4769-8f94-5ae91ddc9537	2024-06-06	Warnings	Exact identifier application applno (ANDA): 074164 application number: ANDA074164
Miconazole 7	MICONAZOLE NITRATE	Cardinal Health (Leader) 70000	5081411c-02d0-4f7d-8496-d6adccbe00ae	2024-03-18	Warnings	Exact identifier application applno (ANDA): 074164 application number: ANDA074164
Miconazole 7	MICONAZOLE NITRATE	H2-Pharma, LLC	4bf1a555-a24f-4807-ac13-db19c55cf280	2023-01-13	Warnings	Exact identifier application applno (ANDA): 074164 application number: ANDA074164
Miconazole 7	MICONAZOLE NITRATE	H2-Pharma, LLC	67dc7d38-a663-48d5-9abf-b3bd8dc0eddf	2023-01-13	Warnings	Exact identifier application applno (ANDA): 074164 application number: ANDA074164
Miconazole 7	MICONAZOLE NITRATE	QUALITY CHOICE (Chain Drug Marketing Association)	68667d2e-d4d0-46e7-9d84-0f23fdac1cf7	2022-09-30	Warnings	Exact identifier application applno (ANDA): 074164 application number: ANDA074164

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
998540	miconazole nitrate 2 % Vaginal Cream	PSN	c33f7d75-d976-7f46-e053-2a95a90a98ec	2
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	c33f7d75-d976-7f46-e053-2a95a90a98ec	2
998540	miconazole nitrate 2 % Vaginal Cream	SY	c33f7d75-d976-7f46-e053-2a95a90a98ec	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2419-7	68071241907	1 TUBE, WITH APPLICATOR in 1 CARTON (68071-2419-7) > 45 g in 1 TUBE, WITH APPLICATOR	2021-05-26	0000-00-00	No	No	Current