NDC 57844-198

ORAP

Pimozide

ORAP is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Teva Select Brands. The primary component is Pimozide.

• Product ID: 57844-198_f78c27e5-cb6b-4018-a64c-53c9945bfcec
• NDC: 57844-198
• Product Type: Human Prescription Drug
• Proprietary Name: ORAP
• Generic Name: Pimozide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-10-31
• Marketing Category: NDA / NDA
• Application Number: NDA017473
• Labeler Name: Teva Select Brands
• Substance Name: PIMOZIDE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Typical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 57844-198-01

100 TABLET in 1 BOTTLE (57844-198-01)

• Marketing Start Date: 2014-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57844-198-01 [57844019801]

ORAP TABLET

• Marketing Category: NDA
• Application Number: NDA017473
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-10-31
• Marketing End Date: 2019-04-08

Drug Details

Active Ingredients

Ingredient	Strength
PIMOZIDE	2 mg/1

OpenFDA Data

• SPL SET ID: 90c0086a-b62c-4cdd-a6af-2efed69cfd4d
• Manufacturer:
  • Teva Select Brands
• UNII:
  • 1HIZ4DL86F
• RxNorm Concept Unique ID - RxCUI:
  • 312439
  • 262226
  • 201653
  • 198103
• UPC Code:
  • 0357844151017

Pharmacological Class

• Typical Antipsychotic [EPC]

Medicade Reported Pricing

57844019801 ORAP 2 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "ORAP" or generic name "Pimozide"

NDC	Brand Name	Generic Name
57844-151	ORAP	Pimozide
57844-198	ORAP	Pimozide
49884-347	Pimozide	Pimozide
49884-348	Pimozide	Pimozide