FDA.reportPublic FDA data

Primaquine Phosphate

Product NDC
0024-1596
11-digit product format
000241596
Labeler code
0024
Product ID
0024-1596_7e15f87d-f34f-4ec2-9da8-a041db792623
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primaquine Phosphate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sanofi-Aventis U.S. LLC
Application
NDA008316
Marketing category
NDA
Marketing start
2011-04-15
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
eb8524b4-2da6-dfe9-e2a2-512a68ffe536Product name220160815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0024-1596-01Primaquine Phosphate100 in 1 BOTTLETABLET, FILM COATED10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-1596-01EA - Each0024-159605cf2232-eb84-4719-92fe-5974e86a7beb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Primaquine PhosphateACTIVE INGREDIENTH0982HF78BPRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]9
primaquineACTIVE MOIETYMVR3634GX1PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]9
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZPRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]9
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UPRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]9
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]9
Hypromellose 2910 (15000 MPA.S)INACTIVE INGREDIENT288VBX44JCPRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]9
LactoseINACTIVE INGREDIENTJ2B2A4N98GPRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]9
Magnesium StearateINACTIVE INGREDIENT70097M6I30PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]9
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQPRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]9
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]9
Starch, CornINACTIVE INGREDIENTO8232NY3SJPRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]9
TalcINACTIVE INGREDIENT7SEV7J4R1UPRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]9
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPPRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-1596PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]19Current NDC, Legacy NDC, 1 package rows20250430_1bfbf4ae-81b8-4160-a00d-6322aadd4b59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904170primaquine phosphate 26.3 MG Oral TabletPSN1bfbf4ae-81b8-4160-a00d-6322aadd4b5920
904170primaquine phosphate 26.3 MG Oral TabletSCD1bfbf4ae-81b8-4160-a00d-6322aadd4b5920
904170primaquine phosphate 26.3 MG (primaquine 15 MG) Oral TabletSY1bfbf4ae-81b8-4160-a00d-6322aadd4b5920

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0024-1596-0100024159601100 TABLET, FILM COATED in 1 BOTTLE (0024-1596-01) 2011-04-150000-00-00NoNoCurrent