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NDC 76385-0102-01 Primaquine Phosphate 15 mg/1 Details
Primaquine Phosphate 15 mg/1
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.
MedlinePlus Drug Summary
Primaquine is used alone or with another medication to treat malaria (a serious infection that is spread by mosquitoes in certain parts of the world and can cause death) and to prevent the disease from coming back in people that are infected with malaria. Primaquine is in a class of medications called antimalarials. It works by killing the organisms that cause malaria.
Related Packages: 76385-0102-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Primaquine
Product Information
NDC | 76385-0102 |
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Product ID | 76385-102_6b56e67f-8e04-4efd-a12a-4c82596f3adc |
Associated GPIs | 13000030100310 |
GCN Sequence Number | 009577 |
GCN Sequence Number Description | primaquine phosphate TABLET 26.3 MG ORAL |
HIC3 | W4A |
HIC3 Description | ANTIMALARIAL DRUGS |
GCN | 42910 |
HICL Sequence Number | 004148 |
HICL Sequence Number Description | PRIMAQUINE PHOSPHATE |
Brand/Generic | Generic |
Proprietary Name | Primaquine Phosphate |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Primaquine Phosphate |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 15 |
Active Ingredient Units | mg/1 |
Substance Name | PRIMAQUINE PHOSPHATE |
Labeler Name | Bayshore Pharmaceuticals, LLC |
Pharmaceutical Class | Antimalarial [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA204476 |
Listing Certified Through | 2025-12-31 |
Package
NDC 76385-0102-01 (76385010201)
NDC Package Code | 76385-102-01 |
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Billing NDC | 76385010201 |
Package | 100 TABLET in 1 BOTTLE (76385-102-01) |
Marketing Start Date | 2014-08-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |