Miconazole 7

Product NDC: 49348-833
11-digit product format: 493480833
Labeler code: 49348
Product ID: 49348-833_274e7b2b-9aaa-4b8e-8cc0-a88ca1cbecde
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: SUPPOSITORY
Route: VAGINAL
Labeler: Strategic Sourcing Services LLC
Application: ANDA073507
Marketing category: ANDA
Marketing start: 2011-12-09
Marketing end: 2026-12-09
Substance: MICONAZOLE NITRATE
Active strength: 100 mg/1
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
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
A073507-001	MICONAZOLE NITRATE	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL			1993-11-19

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	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073507-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1993-11-19	`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: Miconazole 7

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICONAZOLE NITRATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VW4H1CYW1K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992780	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
89132802-beb1-42f4-8da4-39918fc5c4dd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
49348-833-61	Miconazole 7	7 in 1 APPLICATOR	SUPPOSITORY	7		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-833-61	EA - Each	49348-833	91bde22e-afb4-40cf-9552-9e3aeca0a3db	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	MICONAZOLE 7 (MICONAZOLE NITRATE) SUPPOSITORY [MCKESSON]	3
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	MICONAZOLE 7 (MICONAZOLE NITRATE) SUPPOSITORY [MCKESSON]	3
HYDROGENATED PALM KERNEL OIL	INACTIVE INGREDIENT	FM8D1RE2VP	MICONAZOLE 7 (MICONAZOLE NITRATE) SUPPOSITORY [MCKESSON]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-833	MICONAZOLE 7 (MICONAZOLE NITRATE) SUPPOSITORY [STRATEGIC SOURCING SERVICES LLC]	12	Current NDC, Legacy NDC, 1 package rows	20241122_89132802-beb1-42f4-8da4-39918fc5c4dd.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole 7	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	89132802-beb1-42f4-8da4-39918fc5c4dd	2025-09-09	Warnings	Exact identifier application applno (ANDA): 073507 application number: ANDA073507 ndc (product): 49348-833

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
992780	miconazole nitrate 100 MG Vaginal Insert	PSN	89132802-beb1-42f4-8da4-39918fc5c4dd	14
992780	miconazole nitrate 100 MG Vaginal Insert	SCD	89132802-beb1-42f4-8da4-39918fc5c4dd	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-833-61	49348083361	7 SUPPOSITORY in 1 APPLICATOR (49348-833-61)	7 suppository	2011-12-09	2026-12-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Miconazole Nitrate Vaginal Suppositories, USP	Strategic Sourcing Services LLC	2025-09-09	HUMAN OTC DRUG LABEL	14