FDA.reportPublic FDA data

Primaquine Phosphate

Product NDC
43063-721
11-digit product format
430630721
Labeler code
43063
Product ID
43063-721_51a584d0-f172-e260-e063-6394a90a4547
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Primaquine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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
43063-721-14Primaquine Phosphate14 in 1 BOTTLE, PLASTICTABLET1412
43063-721-28Primaquine Phosphate28 in 1 BOTTLE, PLASTICTABLET2812

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-721-01EA - Each43063-7215898ba99-642e-440a-8164-efe663215e1c12016-12-07
43063-721-14EA - Each43063-721a722c3e2-3a17-4965-951a-27bb822ddf9512016-11-08
43063-721-28EA - Each43063-7213caf38ed-9419-4004-b4a4-562406a0ac0012016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-721PRIMAQUINE PHOSPHATE TABLET [PD-RX PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 2 package rows20240815_3f16166d-678e-51aa-e054-00144ff88e88.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-721-144306307211414 TABLET in 1 BOTTLE, PLASTIC (43063-721-14) 14 tablet2016-10-170000-00-00NoNoCurrent
43063-721-284306307212828 TABLET in 1 BOTTLE, PLASTIC (43063-721-28) 28 tablet2016-10-170000-00-00NoNoCurrent