Lagicam

Product NDC: 50066-070
11-digit product format: 500660070
Labeler code: 50066
Product ID: 50066-070_38f5f7e1-41c1-166e-e063-6394a90a7f56
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: CREAM
Route: VAGINAL
Labeler: Genomma Lab USA, Inc.
Application: ANDA076773
Marketing category: ANDA
Marketing start: 2005-03-02
Substance: MICONAZOLE NITRATE
Active strength: 40 mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
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
A076773-001	MICONAZOLE 3	MICONAZOLE NITRATE	4%	CREAM / VAGINAL			2005-03-02

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	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`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: Lagicam
Brand name suffix: antifungal
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICONAZOLE NITRATE	40 mg/g

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998544	Internal RxNorm lookup
1440002	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
85043273-7411-48f5-8ad4-3f00e03cafa3	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	SPL version
50066-070-01	Lagicam antifungal	1 in 1 CARTON	CREAM	1	6
50066-070-01	Lagicam antifungal	25 g in 1 TUBE, WITH APPLICATOR	CREAM	25	6
50066-070-03	Lagicam antifungal	25 g in 1 TUBE, WITH APPLICATOR	CREAM	25	6
50066-070-03	Lagicam antifungal	1 in 1 CARTON	CREAM	1	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Miconazole Nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	LAGICAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [GENOMMA LAB USA, INC.]	2
miconazole	ACTIVE MOIETY	7NNO0D7S5M	LAGICAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [GENOMMA LAB USA, INC.]	2
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	LAGICAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [GENOMMA LAB USA, INC.]	2
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	LAGICAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [GENOMMA LAB USA, INC.]	2
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	LAGICAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [GENOMMA LAB USA, INC.]	2
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	LAGICAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [GENOMMA LAB USA, INC.]	2
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	LAGICAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [GENOMMA LAB USA, INC.]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	LAGICAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [GENOMMA LAB USA, INC.]	2
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	LAGICAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [GENOMMA LAB USA, INC.]	2
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	LAGICAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [GENOMMA LAB USA, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	LAGICAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [GENOMMA LAB USA, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50066-070	LAGICAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [GENOMMA LAB USA, INC.]	5	Current NDC, Legacy NDC, 4 package rows	20230912_85043273-7411-48f5-8ad4-3f00e03cafa3.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole 3	MICONAZOLE NITRATE	TARGET Corporation	12a2e441-4fdf-4c5e-b033-ba05ef12fc2f	2025-07-18	Warnings	Exact identifier application applno (ANDA): 076773 application number: ANDA076773
Lagicam antifungal	MICONAZOLE NITRATE	Genomma Lab USA, Inc.	85043273-7411-48f5-8ad4-3f00e03cafa3	2025-07-02	Warnings	Exact identifier application applno (ANDA): 076773 application number: ANDA076773 ndc (product): 50066-070
Miconazole Nitrate	MICONAZOLE NITRATE	Sun Pharmaceutical Industries, Inc.	eaca3e39-6ea0-4d7e-803c-db22024ad9f9	2025-07-01	Warnings	Exact identifier application applno (ANDA): 076773 application number: ANDA076773

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
1440002	lagicam 4 % Vaginal Cream	PSN	85043273-7411-48f5-8ad4-3f00e03cafa3	6
998544	miconazole nitrate 4 % Vaginal Cream	PSN	85043273-7411-48f5-8ad4-3f00e03cafa3	6
1440002	miconazole nitrate 40 MG/ML Vaginal Cream [Lagicam]	SBD	85043273-7411-48f5-8ad4-3f00e03cafa3	6
998544	miconazole nitrate 40 MG/ML Vaginal Cream	SCD	85043273-7411-48f5-8ad4-3f00e03cafa3	6
1440002	Lagicam 4 % Vaginal Cream	SY	85043273-7411-48f5-8ad4-3f00e03cafa3	6
1440002	Lagicam 40 MG/ML Vaginal Cream	SY	85043273-7411-48f5-8ad4-3f00e03cafa3	6
998544	miconazole nitrate 4 % Vaginal Cream	SY	85043273-7411-48f5-8ad4-3f00e03cafa3	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50066-070-01	50066007001	1 TUBE, WITH APPLICATOR in 1 CARTON (50066-070-01) / 25 g in 1 TUBE, WITH APPLICATOR	2023-09-11		No	No	Current
50066-070-03	50066007003	1 TUBE, WITH APPLICATOR in 1 CARTON (50066-070-03) / 25 g in 1 TUBE, WITH APPLICATOR	2013-10-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lagicam antifungal	Genomma Lab USA, Inc. \| Sun Pharma Canada Inc.	2025-07-02	HUMAN OTC DRUG LABEL	6