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NDC 45802-0042-02 Clindesse 100 mg/5g Details
Clindesse 100 mg/5g
Clindesse is a VAGINAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is CLINDAMYCIN PHOSPHATE.
MedlinePlus Drug Summary
Vaginal clindamycin is used to treat bacterial vaginosis (an infection caused by an overgrowth of harmful bacteria in the vagina). Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria. Vaginal clindamycin cannot be used to treat vaginal irritation caused by yeast infections or by sexually transmitted diseases such as chlamydia and trichomoniasis.
Related Packages: 45802-0042-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Clindamycin Vaginal
Product Information
| NDC | 45802-0042 |
|---|---|
| Product ID | 45802-042_8b0f9cbc-5e92-4583-a6a3-f7524a4cb3da |
| Associated GPIs | 55100018113720 |
| GCN Sequence Number | 058439 |
| GCN Sequence Number Description | clindamycin phosphate CRM ER (G) 2 % VAGINAL |
| HIC3 | Q4W |
| HIC3 Description | VAGINAL ANTIBIOTICS |
| GCN | 23876 |
| HICL Sequence Number | 004045 |
| HICL Sequence Number Description | CLINDAMYCIN PHOSPHATE |
| Brand/Generic | Brand |
| Proprietary Name | Clindesse |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | clindamycin phosphate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | VAGINAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/5g |
| Substance Name | CLINDAMYCIN PHOSPHATE |
| Labeler Name | Padagis Israel Pharmaceuticals Ltd |
| Pharmaceutical Class | Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA050793 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 45802-0042-02 (45802004202)
| NDC Package Code | 45802-042-02 |
|---|---|
| Billing NDC | 45802004202 |
| Package | 1 APPLICATOR in 1 CARTON (45802-042-02) / 5 g in 1 APPLICATOR |
| Marketing Start Date | 2015-07-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |