NDC 0378-0631

Iloperidone

Iloperidone

Iloperidone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Iloperidone.

• Product ID: 0378-0631_9721328c-453d-4861-b352-22ee78a1a7f5
• NDC: 0378-0631
• Product Type: Human Prescription Drug
• Proprietary Name: Iloperidone
• Generic Name: Iloperidone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-03-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207231
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: ILOPERIDONE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0378-0631-01

100 TABLET in 1 BOTTLE (0378-0631-01)

• Marketing Start Date: 2017-03-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-0631-88 [00378063188]

Iloperidone TABLET

• Marketing Category: ANDA
• Application Number: ANDA207231
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-03-20

NDC 0378-0631-01 [00378063101]

Iloperidone TABLET

• Marketing Category: ANDA
• Application Number: ANDA207231
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-03-20

NDC 0378-0631-91 [00378063191]

Iloperidone TABLET

• Marketing Category: ANDA
• Application Number: ANDA207231
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-03-20

Drug Details

Active Ingredients

Ingredient	Strength
ILOPERIDONE	2 mg/1

OpenFDA Data

• SPL SET ID: eeb0fcfd-e4e8-4fb1-9635-901dc9446235
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • VPO7KJ050N
• RxNorm Concept Unique ID - RxCUI:
  • 848732
  • 848736
  • 848740
  • 848744
  • 848748
  • 848728
  • 848722
• UPC Code:
  • 0303780630918
  • 0303780631915
  • 0303780633919
  • 0303780636910
  • 0303780632912
  • 0303780635913
  • 0303780634916

Pharmacological Class

• Atypical Antipsychotic [EPC]
• Atypical Antipsychotic [EPC]

NDC Crossover Matching brand name "Iloperidone" or generic name "Iloperidone"

NDC	Brand Name	Generic Name
0378-0630	Iloperidone	Iloperidone
0378-0631	Iloperidone	Iloperidone
0378-0632	Iloperidone	Iloperidone
0378-0633	Iloperidone	Iloperidone
0378-0634	Iloperidone	Iloperidone
0378-0635	Iloperidone	Iloperidone
0378-0636	Iloperidone	Iloperidone
51672-4178	Iloperidone	Iloperidone
51672-4179	Iloperidone	Iloperidone
51672-4180	Iloperidone	Iloperidone
51672-4181	Iloperidone	Iloperidone
51672-4182	Iloperidone	Iloperidone
51672-4183	Iloperidone	Iloperidone
51672-4184	Iloperidone	Iloperidone
51672-4213	Iloperidone	Iloperidone
43068-101	Fanapt	iloperidone
43068-102	Fanapt	iloperidone
43068-104	Fanapt	iloperidone
43068-106	Fanapt	iloperidone
43068-108	Fanapt	iloperidone
43068-110	Fanapt	iloperidone
43068-112	Fanapt	iloperidone
43068-113	Fanapt	iloperidone
43068-901	Fanapt	iloperidone
43068-902	Fanapt	iloperidone
43068-903	Fanapt	iloperidone
69189-0597	FANAPT	Iloperidone
69189-0665	Fanapt	iloperidone
70518-1867	Fanapt	iloperidone