NDC 64011-124

Clindesse

Clindamycin Phosphate

Clindesse is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by Ther-rx Corporation. The primary component is Clindamycin Phosphate.

• Product ID: 64011-124_a96a8d64-4abd-4ef0-a2db-558d973c4029
• NDC: 64011-124
• Product Type: Human Prescription Drug
• Proprietary Name: Clindesse
• Generic Name: Clindamycin Phosphate
• Dosage Form: Cream
• Route of Administration: VAGINAL
• Marketing Start Date: 2009-11-01
• Marketing Category: NDA / NDA
• Application Number: NDA050793
• Labeler Name: Ther-Rx Corporation
• Substance Name: CLINDAMYCIN PHOSPHATE
• Active Ingredient Strength: 20 mg/g
• Pharm Classes: Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 64011-124-08

5 g in 1 APPLICATOR (64011-124-08)

• Marketing Start Date: 2009-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64011-124-27 [64011012427]

Clindesse CREAM

• Marketing Category: NDA
• Application Number: NDA050793
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-03-01
• Inactivation Date: 2020-01-31

NDC 64011-124-08 [64011012408]

Clindesse CREAM

• Marketing Category: NDA
• Application Number: NDA050793
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2009-11-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
CLINDAMYCIN PHOSPHATE	20 mg/g

OpenFDA Data

• SPL SET ID: dac31f82-b35e-49b9-aff9-f0101292f1be
• Manufacturer:
  • Ther-Rx Corporation
• UNII:
  • EH6D7113I8
• RxNorm Concept Unique ID - RxCUI:
  • 309337
  • 602427

Pharmacological Class

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

Medicade Reported Pricing

64011012408 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