NDC 76385-102

Primaquine Phosphate

Primaquine Phosphate

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

Product ID76385-102_1a92fd76-5900-4661-b898-2221ff6f27d3
NDC76385-102
Product TypeHuman Prescription Drug
Proprietary NamePrimaquine Phosphate
Generic NamePrimaquine Phosphate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-08-01
Marketing CategoryANDA / ANDA
Application NumberANDA204476
Labeler NameBayshore Pharmaceuticals, LLC
Substance NamePRIMAQUINE PHOSPHATE
Active Ingredient Strength15 mg/1
Pharm ClassesAntimalarial [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 76385-102-01

100 TABLET in 1 BOTTLE (76385-102-01)
Marketing Start Date2014-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76385-102-01 [76385010201]

Primaquine Phosphate TABLET
Marketing CategoryANDA
Application NumberANDA204476
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-08-01

Drug Details

Active Ingredients

IngredientStrength
PRIMAQUINE PHOSPHATE15 mg/1

OpenFDA Data

SPL SET ID:0c8c2bc6-428b-40b6-8114-6df80290878d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904170
  • Pharmacological Class

    • Antimalarial [EPC]

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

    NDCBrand NameGeneric Name
    0024-1596Primaquine PhosphatePrimaquine Phosphate
    0440-8187Primaquine PhosphatePrimaquine Phosphate
    33261-671Primaquine PhosphatePrimaquine Phosphate
    42291-510PRIMAQUINE PHOSPHATEPRIMAQUINE PHOSPHATE
    43063-225Primaquine PhosphatePrimaquine Phosphate
    43063-721Primaquine PhosphatePrimaquine Phosphate
    50742-191PRIMAQUINE PHOSPHATEPRIMAQUINE PHOSPHATE
    60429-035Primaquine PhosphatePrimaquine Phosphate
    76385-102Primaquine PhosphatePrimaquine Phosphate

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