NDC 50742-191

PRIMAQUINE PHOSPHATE

Primaquine Phosphate

PRIMAQUINE PHOSPHATE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Primaquine Phosphate.

• Product ID: 50742-191_aa39ce08-d1dc-463c-95b7-fbd85048767a
• NDC: 50742-191
• Product Type: Human Prescription Drug
• Proprietary Name: PRIMAQUINE PHOSPHATE
• Generic Name: Primaquine Phosphate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-01-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206043
• Labeler Name: Ingenus Pharmaceuticals, LLC
• Substance Name: PRIMAQUINE PHOSPHATE
• Active Ingredient Strength: 15 mg/1
• Pharm Classes: Antimalarial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50742-191-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-01)

• Marketing Start Date: 2018-01-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50742-191-05 [50742019105]

PRIMAQUINE PHOSPHATE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA206043
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-01-23

NDC 50742-191-01 [50742019101]

PRIMAQUINE PHOSPHATE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA206043
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-01-23

Drug Details

Active Ingredients

Ingredient	Strength
PRIMAQUINE PHOSPHATE	15 mg/1

OpenFDA Data

• SPL SET ID: 09531382-2e06-4164-a7e1-169a1488788a
• Manufacturer:
  • Ingenus Pharmaceuticals, LLC
• UNII:
  • H0982HF78B
• RxNorm Concept Unique ID - RxCUI:
  • 904170
• UPC Code:
  • 0350742191017
  • 0350742191055

Pharmacological Class

• Antimalarial [EPC]
• Antimalarial [EPC]

NDC Crossover Matching brand name "PRIMAQUINE PHOSPHATE" or generic name "Primaquine Phosphate"

NDC	Brand Name	Generic Name
0024-1596	Primaquine Phosphate	Primaquine Phosphate
0440-8187	Primaquine Phosphate	Primaquine Phosphate
33261-671	Primaquine Phosphate	Primaquine Phosphate
42291-510	PRIMAQUINE PHOSPHATE	PRIMAQUINE PHOSPHATE
43063-225	Primaquine Phosphate	Primaquine Phosphate
43063-721	Primaquine Phosphate	Primaquine Phosphate
50742-191	PRIMAQUINE PHOSPHATE	PRIMAQUINE PHOSPHATE
60429-035	Primaquine Phosphate	Primaquine Phosphate
76385-102	Primaquine Phosphate	Primaquine Phosphate