QUININE SULFATE

Product NDC
50742-238
11-digit product format
507420238
Labeler code
50742
Product ID
50742-238_0a0b38d3-828f-4828-8d8c-92933872aa4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
QUININE SULFATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA204372
Marketing category
ANDA
Marketing start
2017-12-11
Substance
QUININE SULFATE
Active strength
324 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
QUININE SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUININE SULFATE324 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKF7Z0E0Q2B
Rxcui997010

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
22bca8fc-c2b1-897d-b515-117a7522ccaeProduct name320150731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50742-238-30QUININE SULFATE30 in 1 BOTTLE, PLASTICCAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-238-30EA - Each50742-2383e08c1cc-e9b3-4ef2-ae69-8bf137cce96e12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-238QUININE SULFATE CAPSULE [INGENUS PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 1 package rows20241024_b2f73c64-b92c-49bf-ad39-e32ac83e4d3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997010quiNINE sulfate 324 MG Oral CapsulePSNb2f73c64-b92c-49bf-ad39-e32ac83e4d3d5
997010quinine sulfate 324 MG Oral CapsuleSCDb2f73c64-b92c-49bf-ad39-e32ac83e4d3d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-238-305074202383030 CAPSULE in 1 BOTTLE, PLASTIC (50742-238-30) 30 capsule2017-12-110000-00-00NoNoCurrent