NDC 0078-0650

FARYDAK

Panobinostat

FARYDAK is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Panobinostat Lactate.

• Product ID: 0078-0650_1de1e12a-af22-4b99-9116-585bcfc1e304
• NDC: 0078-0650
• Product Type: Human Prescription Drug
• Proprietary Name: FARYDAK
• Generic Name: Panobinostat
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2015-02-23
• Marketing End Date: 2021-02-28
• Marketing Category: NDA / NDA
• Application Number: NDA205353
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: PANOBINOSTAT LACTATE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Histone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
• NDC Exclude Flag: N

Packaging

NDC 0078-0650-06

6 CAPSULE in 1 BLISTER PACK (0078-0650-06)

• Marketing Start Date: 2015-02-23
• Marketing End Date: 2023-01-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0650-06 [00078065006]

FARYDAK CAPSULE

• Marketing Category: NDA
• Application Number: NDA205353
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-02-23
• Marketing End Date: 2023-01-31

Drug Details

Active Ingredients

Ingredient	Strength
PANOBINOSTAT LACTATE	10 mg/1

OpenFDA Data

• SPL SET ID: 7774972a-eeaa-4b9a-9e56-3fc1b968e86a
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • HN0T99OO4V
• RxNorm Concept Unique ID - RxCUI:
  • 1603361
  • 1603363
  • 1603365
  • 1603367
  • 1603355
  • 1603369

Pharmacological Class

• Histone Deacetylase Inhibitor [EPC]
• Histone Deacetylase Inhibitors [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]

NDC Crossover Matching brand name "FARYDAK" or generic name "Panobinostat"

NDC	Brand Name	Generic Name
0078-0650	FARYDAK	panobinostat
0078-0651	FARYDAK	panobinostat
0078-0652	FARYDAK	panobinostat
73116-100	FARYDAK	panobinostat
73116-101	FARYDAK	panobinostat
73116-102	FARYDAK	panobinostat