NDC 45802-042

Clindesse

Clindamycin Phosphate

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.

• Product ID: 45802-042_0640a4a5-8ff8-4fd5-a25c-9ae321af586e
• NDC: 45802-042
• Product Type: Human Prescription Drug
• Proprietary Name: Clindesse
• Generic Name: Clindamycin Phosphate
• Dosage Form: Cream
• Route of Administration: VAGINAL
• Marketing Start Date: 2015-07-03
• Marketing Category: NDA / NDA
• Application Number: NDA050793
• Labeler Name: Padagis Israel Pharmaceuticals Ltd
• Substance Name: CLINDAMYCIN PHOSPHATE
• Active Ingredient Strength: 100 mg/5g
• Pharm Classes: Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Neuromuscular Blockade [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 45802-042-01

1 APPLICATOR in 1 CARTON (45802-042-01) > 5 g in 1 APPLICATOR

• Marketing Start Date: 2015-07-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45802-042-01 [45802004201]

Clindesse CREAM

• Marketing Category: NDA
• Application Number: NDA050793
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2015-07-03

NDC 45802-042-02 [45802004202]

Clindesse CREAM

• Marketing Category: NDA
• Application Number: NDA050793
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-07-03

Drug Details

Active Ingredients

Ingredient	Strength
CLINDAMYCIN PHOSPHATE	100 mg/5g

OpenFDA Data

• SPL SET ID: fe8bb204-f173-44fe-803b-b08f2ec5aa31
• Manufacturer:
  • Perrigo New York Inc
• UNII:
  • EH6D7113I8
• RxNorm Concept Unique ID - RxCUI:
  • 309337
  • 602427

Pharmacological Class

• Decreased Sebaceous Gland Activity [PE]
• Lincosamide Antibacterial [EPC]
• Lincosamides [CS]

Medicade Reported Pricing

45802042578 FEXOFENADINE HCL 60 MG TABLET

Pricing Unit: EA | Drug Type:

45802042337 DESONIDE 0.05% OINTMENT

Pricing Unit: GM | Drug Type:

45802042335 DESONIDE 0.05% OINTMENT

Pricing Unit: GM | Drug Type:

45802042237 DESONIDE 0.05% CREAM

Pricing Unit: GM | Drug Type:

45802042235 DESONIDE 0.05% CREAM

Pricing Unit: GM | Drug Type:

45802004201 CLINDESSE 2% VAGINAL CREAM

Pricing Unit: GM | Drug Type:

NDC Crossover Matching brand name "Clindesse" or generic name "Clindamycin Phosphate"

NDC	Brand Name	Generic Name
45802-042	Clindesse	Clindesse
64011-124	Clindesse	Clindesse
0009-0302	Cleocin Phosphate	clindamycin phosphate
0009-0602	Cleocin Phosphate	clindamycin phosphate
0009-0728	Cleocin Phosphate	clindamycin phosphate
0009-0775	Cleocin Phosphate	clindamycin phosphate
0009-0870	Cleocin Phosphate	clindamycin phosphate