PRIMAQUINE PHOSPHATE

Product NDC
42291-510
11-digit product format
422910510
Labeler code
42291
Product ID
42291-510_4ba945a5-47a2-e791-e063-6294a90a9f8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRIMAQUINE PHOSPHATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA206043
Marketing category
ANDA
Marketing start
2019-02-21
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
42291-510-01PRIMAQUINE PHOSPHATE100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-510-01EA - Each42291-5108657f226-f051-4b62-beed-d235aec016fb12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-510PRIMAQUINE PHOSPHATE TABLET, FILM COATED [AVKARE]3Current NDC, Legacy NDC, 1 package rows20240110_82465385-4602-7f46-e053-2991aa0a9fdf.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-510-0142291051001100 TABLET, FILM COATED in 1 BOTTLE (42291-510-01) 2019-02-210000-00-00NoNoCurrent