FDA.reportPublic FDA data

PRIMAQUINE PHOSPHATE

Product NDC
50742-191
11-digit product format
507420191
Labeler code
50742
Product ID
50742-191_0fb59114-6477-4616-88ab-48fdc00858f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRIMAQUINE PHOSPHATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA206043
Marketing category
ANDA
Marketing start
2018-01-23
Substance
PRIMAQUINE PHOSPHATE
Active strength
15 mg/1
Pharmacologic classes
Antimalarial [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRIMAQUINE PHOSPHATE
Listing expiration
2026-12-31

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
50742-191-01PRIMAQUINE PHOSPHATE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004
50742-191-05PRIMAQUINE PHOSPHATE500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-191-05EA - Each50742-19193ec9c45-534d-48af-8e4a-2506bbddf4e712019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-191PRIMAQUINE PHOSPHATE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 2 package rows20181220_09531382-2e06-4164-a7e1-169a1488788a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904170primaquine phosphate 26.3 MG Oral TabletPSN82465385-4602-7f46-e053-2991aa0a9fdf5
904170primaquine phosphate 26.3 MG Oral TabletSCD82465385-4602-7f46-e053-2991aa0a9fdf5
904170primaquine phosphate 26.3 MG (primaquine 15 MG) Oral TabletSY82465385-4602-7f46-e053-2991aa0a9fdf5
904170primaquine phosphate 26.3 MG Oral TabletPSN09531382-2e06-4164-a7e1-169a1488788a4
904170primaquine phosphate 26.3 MG Oral TabletSCD09531382-2e06-4164-a7e1-169a1488788a4
904170primaquine phosphate 26.3 MG (primaquine 15 MG) Oral TabletSY09531382-2e06-4164-a7e1-169a1488788a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-191-0150742019101100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-01) 2018-01-230000-00-00NoNoCurrent
50742-191-0550742019105500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-05) 2018-01-230000-00-00NoNoCurrent