NDC 16781-462

Clindagel

Clindamycin

Clindagel is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us Llc. The primary component is Clindamycin Phosphate.

• Product ID: 16781-462_4e17180d-3e03-4c06-a12d-12297751a526
• NDC: 16781-462
• Product Type: Human Prescription Drug
• Proprietary Name: Clindagel
• Generic Name: Clindamycin
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-11-25
• Marketing Category: NDA / NDA
• Application Number: NDA050782
• Labeler Name: Bausch Health US LLC
• Substance Name: CLINDAMYCIN PHOSPHATE
• Active Ingredient Strength: 1 g/10mL
• Pharm Classes: Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 16781-462-06

6 BOTTLE in 1 CARTON (16781-462-06) > 7.3 mL in 1 BOTTLE

• Marketing Start Date: 2015-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16781-462-75 [16781046275]

Clindagel GEL

• Marketing Category: NDA
• Application Number: NDA050782
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-11-25

NDC 16781-462-40 [16781046240]

Clindagel GEL

• Marketing Category: NDA
• Application Number: NDA050782
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-11-25
• Marketing End Date: 2013-12-31

NDC 16781-462-06 [16781046206]

Clindagel GEL

• Marketing Category: NDA
• Application Number: NDA050782
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-07-01

NDC 16781-462-07 [16781046207]

Clindagel GEL

• Marketing Category: NDA
• Application Number: NDA050782
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-11-25
• Marketing End Date: 2017-06-30

Drug Details

Active Ingredients

Ingredient	Strength
CLINDAMYCIN PHOSPHATE	1 g/10mL

OpenFDA Data

• SPL SET ID: f7b4e985-719a-4547-b624-94612d520991
• Manufacturer:
  • Onset Dermatologics LLC
• UNII:
  • EH6D7113I8
• RxNorm Concept Unique ID - RxCUI:
  • 309332
  • 351330

Pharmacological Class

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

NDC Crossover Matching brand name "Clindagel" or generic name "Clindamycin"

NDC	Brand Name	Generic Name
16781-462	Clindagel	CLINDAMYCIN
51662-1437	CLINDAMYCIN	CLINDAMYCIN
52584-814	CLINDAMYCIN	CLINDAMYCIN
52584-815	CLINDAMYCIN	CLINDAMYCIN
52584-816	CLINDAMYCIN	CLINDAMYCIN
67457-814	Clindamycin	Clindamycin
67457-815	Clindamycin	Clindamycin
67457-816	Clindamycin	Clindamycin
67457-817	Clindamycin	Clindamycin
71872-7168	Clindamycin	Clindamycin