gynazole 1
- Product NDC
- 45802-396
- 11-digit product format
- 458020396
- Labeler code
- 45802
- Product ID
- 45802-396_3953738b-1476-4a24-9e07-a7d3866d76a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butoconazole nitrate
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA200923
- Marketing category
- ANDA
- Marketing start
- 2015-04-29
- Substance
- BUTOCONAZOLE NITRATE
- Active strength
- 100 mg/5g
- 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
- gynazole 1
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUTOCONAZOLE NITRATE | 100 mg/5g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4805237NP5 |
| Rxcui | 890785, 890786 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-396-01 | gynazole 1 | 5.8 g in 1 TUBE, WITH APPLICATOR | CREAM | 5.8 | | 6 |
| 45802-396-01 | gynazole 1 | 1 in 1 CARTON | CREAM | 1 | | 6 |
| 45802-396-02 | gynazole 1 | 5.8 g in 1 TUBE, WITH APPLICATOR | CREAM | 5.8 | | 6 |
| 45802-396-02 | gynazole 1 | 1 in 1 CARTON | CREAM | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-396 | GYNAZOLE 1 (BUTOCONAZOLE NITRATE) CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 6 | Current NDC, Legacy NDC, 4 package rows | 20230603_125d8ede-db38-4eb9-a6be-19208687f36a.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 |
|---|
| 45802-396-01 | 45802039601 | 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR | 2015-04-29 | 0000-00-00 | No | No | Current |
| 45802-396-02 | 45802039602 | 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR | 2015-04-29 | 0000-00-00 | Yes | No | Current |