NDC 42806-338

Molindone Hydrochloride

Molindone Hydrochloride

Molindone Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Epic Pharma, Llc. The primary component is Molindone Hydrochloride.

• Product ID: 42806-338_1275e92f-9573-4d0c-8e77-1c9ac47696d2
• NDC: 42806-338
• Product Type: Human Prescription Drug
• Proprietary Name: Molindone Hydrochloride
• Generic Name: Molindone Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-08-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090453
• Labeler Name: EPIC PHARMA, LLC
• Substance Name: MOLINDONE HYDROCHLORIDE
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Typical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 42806-338-01

100 TABLET in 1 BOTTLE (42806-338-01)

• Marketing Start Date: 2018-10-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42806-338-01 [42806033801]

Molindone Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA090453
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-10-17

Drug Details

Active Ingredients

Ingredient	Strength
MOLINDONE HYDROCHLORIDE	25 mg/1

OpenFDA Data

• SPL SET ID: 1275e92f-9573-4d0c-8e77-1c9ac47696d2
• Manufacturer:
  • EPIC PHARMA, LLC
• UNII:
  • 1DWS68PNE6
• RxNorm Concept Unique ID - RxCUI:
  • 1298906
  • 1298816
  • 1298910
• UPC Code:
  • 0342806337011

Pharmacological Class

• Typical Antipsychotic [EPC]

NDC Crossover Matching brand name "Molindone Hydrochloride" or generic name "Molindone Hydrochloride"

NDC	Brand Name	Generic Name
42806-336	Molindone Hydrochloride	Molindone Hydrochloride
42806-337	Molindone Hydrochloride	Molindone Hydrochloride
42806-338	Molindone Hydrochloride	Molindone Hydrochloride