NDC 0378-8134

EVOCLIN

Clindamycin Phosphate

EVOCLIN is a Topical Aerosol, Foam in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Clindamycin Phosphate.

• Product ID: 0378-8134_a9652c37-c59f-43e4-9f79-18a1c1f90b3c
• NDC: 0378-8134
• Product Type: Human Prescription Drug
• Proprietary Name: EVOCLIN
• Generic Name: Clindamycin Phosphate
• Dosage Form: Aerosol, Foam
• Route of Administration: TOPICAL
• Marketing Start Date: 2004-10-22
• Marketing Category: NDA / NDA
• Application Number: NDA050801
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: CLINDAMYCIN PHOSPHATE
• Active Ingredient Strength: 10 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 0378-8134-01

1 CAN in 1 CARTON (0378-8134-01) > 100 g in 1 CAN

• Marketing Start Date: 2019-07-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-8134-99 [00378813499]

EVOCLIN AEROSOL, FOAM

• Marketing Category: NDA
• Application Number: NDA050801
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-12
• Marketing End Date: 2019-07-12

NDC 0378-8134-01 [00378813401]

EVOCLIN AEROSOL, FOAM

• Marketing Category: NDA
• Application Number: NDA050801
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-07-12

NDC 0378-8134-50 [00378813450]

EVOCLIN AEROSOL, FOAM

• Marketing Category: NDA
• Application Number: NDA050801
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-07-12

NDC 0378-8134-06 [00378813406]

EVOCLIN AEROSOL, FOAM

• Marketing Category: NDA
• Application Number: NDA050801
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2004-10-22
• Marketing End Date: 2019-07-12

Drug Details

Active Ingredients

Ingredient	Strength
CLINDAMYCIN PHOSPHATE	10 mg/g

OpenFDA Data

• SPL SET ID: 0bf27280-f246-4087-9dd4-3649c57810bb
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • EH6D7113I8
• RxNorm Concept Unique ID - RxCUI:
  • 477451
  • 544741

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
40076-061	EVOCLIN	EVOCLIN
0378-8134	EVOCLIN	EVOCLIN
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