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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VW4H1CYW1K |
| Rxcui | 998544, 1440002 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | 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 | Uploaded |
|---|
| 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 |
DailyMed RxNorm Mappings#
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 | Historical |
| 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 |