NDC 0187-3050

ONEXTON

Clindamycin Phosphate And Benzoyl Peroxide

ONEXTON is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Valeant Pharmaceuticals North America Llc. The primary component is Clindamycin Phosphate; Benzoyl Peroxide.

• Product ID: 0187-3050_6241718b-98ba-4fab-bcdc-a4215b20f6cc
• NDC: 0187-3050
• Product Type: Human Prescription Drug
• Proprietary Name: ONEXTON
• Generic Name: Clindamycin Phosphate And Benzoyl Peroxide
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2014-11-24
• Marketing Category: NDA / NDA
• Application Number: NDA050819
• Labeler Name: Valeant Pharmaceuticals North America LLC
• Substance Name: CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE
• Active Ingredient Strength: 10 mg/g; mg/g
• Pharm Classes: Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0187-3050-35

3.5 g in 1 TUBE (0187-3050-35)

• Marketing Start Date: 2014-11-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0187-3050-35 [00187305035]

ONEXTON GEL

• Marketing Category: NDA
• Application Number: NDA050819
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-11-24

NDC 0187-3050-50 [00187305050]

ONEXTON GEL

• Marketing Category: NDA
• Application Number: NDA050819
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-11-24

Drug Details

Active Ingredients

Ingredient	Strength
CLINDAMYCIN PHOSPHATE	10 mg/g

OpenFDA Data

• SPL SET ID: 697e760a-c206-4565-8f4e-a8085e215827
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • EH6D7113I8
  • W9WZN9A0GM

Pharmacological Class

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

NDC Crossover Matching brand name "ONEXTON" or generic name "Clindamycin Phosphate And Benzoyl Peroxide"

NDC	Brand Name	Generic Name
0187-3050	ONEXTON	Clindamycin Phosphate and Benzoyl Peroxide
13548-132	Acanya	Clindamycin Phosphate and Benzoyl Peroxide
0187-5190	Benzaclin	Clindamycin phosphate and benzoyl peroxide
66993-949	Clindamycin - Benzoyl Peroxide	clindamycin phosphate and benzoyl peroxide
0378-8688	Clindamycin Phosphate and Benzoyl Peroxide	clindamycin phosphate and benzoyl peroxide
0591-3916	Clindamycin phosphate and benzoyl peroxide	Clindamycin phosphate and benzoyl peroxide
0781-7161	Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate and Benzoyl Peroxide
21922-022	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
51672-1366	Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate and Benzoyl Peroxide
51672-1367	Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate and Benzoyl Peroxide
51672-1403	Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate and Benzoyl Peroxide
63629-8798	Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate and Benzoyl Peroxide
68682-132	Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate and Benzoyl Peroxide
68682-190	Clindamycin phosphate and benzoyl peroxide	Clindamycin phosphate and benzoyl peroxide
70710-1445	Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate and Benzoyl Peroxide
70771-1450	Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate and Benzoyl Peroxide
0145-2371	DUAC	clindamycin phosphate and benzoyl peroxide
43538-176	Neuac	clindamycin phosphate and benzoyl peroxide
43538-177	Neuac Kit	clindamycin phosphate and benzoyl peroxide