NDC 43063-721

Primaquine Phosphate

Primaquine Phosphate

Primaquine Phosphate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Primaquine Phosphate.

• Product ID: 43063-721_5c3bbf1d-7a0b-5e76-e053-2991aa0aac5c
• NDC: 43063-721
• Product Type: Human Prescription Drug
• Proprietary Name: Primaquine Phosphate
• Generic Name: Primaquine Phosphate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-08-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204476
• Labeler Name: PD-Rx Pharmaceuticals, Inc.
• Substance Name: PRIMAQUINE PHOSPHATE
• Active Ingredient Strength: 15 mg/1
• Pharm Classes: Antimalarial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 43063-721-14

14 TABLET in 1 BOTTLE, PLASTIC (43063-721-14)

• Marketing Start Date: 2016-10-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43063-721-28 [43063072128]

Primaquine Phosphate TABLET

• Marketing Category: ANDA
• Application Number: ANDA204476
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-17

NDC 43063-721-01 [43063072101]

Primaquine Phosphate TABLET

• Marketing Category: ANDA
• Application Number: ANDA204476
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-24
• Marketing End Date: 2019-11-07

NDC 43063-721-14 [43063072114]

Primaquine Phosphate TABLET

• Marketing Category: ANDA
• Application Number: ANDA204476
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-17

Drug Details

Active Ingredients

Ingredient	Strength
PRIMAQUINE PHOSPHATE	15 mg/1

OpenFDA Data

• SPL SET ID: 9436c68f-8483-446a-b5b4-cf057c828096
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • H0982HF78B
• RxNorm Concept Unique ID - RxCUI:
  • 904170
• UPC Code:
  • 0343063721018

Pharmacological Class

• 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