FDA.reportPublic FDA data

Primaquine Phosphate

Product NDC
76385-102
11-digit product format
763850102
Labeler code
76385
Product ID
76385-102_8199ccba-1a57-43f1-bbdc-70b6720b72c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primaquine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA204476
Marketing category
ANDA
Marketing start
2014-08-01
Substance
PRIMAQUINE PHOSPHATE
Active strength
15 mg/1
Pharmacologic classes
Antimalarial [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Primaquine Phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRIMAQUINE PHOSPHATE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH0982HF78B
Rxcui904170

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
eb8524b4-2da6-dfe9-e2a2-512a68ffe536Product name220160815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76385-102-01Primaquine Phosphate100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76385-102-01EA - Each76385-10259630686-c837-4b4a-82dc-eeeee31a48ca12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Primaquine PhosphateACTIVE INGREDIENTH0982HF78BPRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]2
primaquineACTIVE MOIETYMVR3634GX1PRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RPRIMAQUINE PHOSPHATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76385-102PRIMAQUINE PHOSPHATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]7Current NDC, Legacy NDC, 1 package rows20250417_0c8c2bc6-428b-40b6-8114-6df80290878d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904170primaquine phosphate 26.3 MG Oral TabletPSN3f16166d-678e-51aa-e054-00144ff88e8812
904170primaquine phosphate 26.3 MG Oral TabletSCD3f16166d-678e-51aa-e054-00144ff88e8812
904170primaquine phosphate 26.3 MG (primaquine 15 MG) Oral TabletSY3f16166d-678e-51aa-e054-00144ff88e8812
904170primaquine phosphate 26.3 MG Oral TabletPSN0c8c2bc6-428b-40b6-8114-6df80290878d9
904170primaquine phosphate 26.3 MG Oral TabletSCD0c8c2bc6-428b-40b6-8114-6df80290878d9
904170primaquine phosphate 26.3 MG (primaquine 15 MG) Oral TabletSY0c8c2bc6-428b-40b6-8114-6df80290878d9
904170primaquine phosphate 26.3 MG Oral TabletPSN5c920cdf-5c1e-43f7-a275-c720400057152
904170primaquine phosphate 26.3 MG Oral TabletSCD5c920cdf-5c1e-43f7-a275-c720400057152
904170primaquine phosphate 26.3 MG (primaquine 15 MG) Oral TabletSY5c920cdf-5c1e-43f7-a275-c720400057152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76385-102-0176385010201100 TABLET in 1 BOTTLE (76385-102-01) 100 tablet2014-08-010000-00-00NoNoCurrent