FDA.reportPublic FDA data

Qualaquin

Product NDC
13310-153
11-digit product format
133100153
Labeler code
13310
Product ID
13310-153_d2f8943c-0442-4ddc-a712-5c1c79fed29b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quinine Sulfate
Dosage form
CAPSULE
Route
ORAL
Labeler
AR Scientific Inc.
Application
NDA021799
Marketing category
NDA
Marketing start
2005-08-12
Marketing end
0000-00-00
Substance
QUININE SULFATE
Active strength
324 mg/1
Pharmacologic classes
Antimalarial [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13310-153-012019-11-27C16284748780-19855d018-e22b-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use QUALAQUIN ® safely and effectively. See full prescribing information for QUALAQUIN ® . QUALAQUIN ® (quinine sulfate) Capsules, USP for Oral use Initial U.S. Approval: 2005 BOXED WARNING (See full prescribing information for complete boxed warning)
13310-153-052019-11-27C16284748780-19855d018-e22b-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use QUALAQUIN ® safely and effectively. See full prescribing information for QUALAQUIN ® . QUALAQUIN ® (quinine sulfate) Capsules, USP for Oral use Initial U.S. Approval: 2005 BOXED WARNING (See full prescribing information for complete boxed warning)
13310-153-072019-11-27C16284748780-19855d018-e22b-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use QUALAQUIN ® safely and effectively. See full prescribing information for QUALAQUIN ® . QUALAQUIN ® (quinine sulfate) Capsules, USP for Oral use Initial U.S. Approval: 2005 BOXED WARNING (See full prescribing information for complete boxed warning)
13310-153-102019-11-27C16284748780-19855d018-e22b-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use QUALAQUIN ® safely and effectively. See full prescribing information for QUALAQUIN ® . QUALAQUIN ® (quinine sulfate) Capsules, USP for Oral use Initial U.S. Approval: 2005 BOXED WARNING (See full prescribing information for complete boxed warning)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13310-153-01Qualaquin100 in 1 BOTTLE, PLASTICCAPSULE10016
13310-153-05Qualaquin500 in 1 BOTTLE, PLASTICCAPSULE50016
13310-153-07Qualaquin30 in 1 BOTTLE, PLASTICCAPSULE3016
13310-153-10Qualaquin1000 in 1 BOTTLE, PLASTICCAPSULE100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13310-153-07EA - Each13310-15313ca9923-f6ff-46d2-9701-b2fdbd1f1e6412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Quinine SulfateACTIVE INGREDIENTKF7Z0E0Q2BQUALAQUIN (QUININE SULFATE) CAPSULE [AR SCIENTIFIC INC.]16
QuinineACTIVE MOIETYA7V27PHC7AQUALAQUIN (QUININE SULFATE) CAPSULE [AR SCIENTIFIC INC.]16
magnesium stearateINACTIVE INGREDIENT70097M6I30QUALAQUIN (QUININE SULFATE) CAPSULE [AR SCIENTIFIC INC.]16
starch, cornINACTIVE INGREDIENTO8232NY3SJQUALAQUIN (QUININE SULFATE) CAPSULE [AR SCIENTIFIC INC.]16
talcINACTIVE INGREDIENT7SEV7J4R1UQUALAQUIN (QUININE SULFATE) CAPSULE [AR SCIENTIFIC INC.]16
QUININE SULFATEACTIVE INGREDIENTKF7Z0E0Q2BQUALAQUIN (QUININE SULFATE) CAPSULE [STAT RX USA LLC]1
QUININEACTIVE MOIETYA7V27PHC7AQUALAQUIN (QUININE SULFATE) CAPSULE [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13310-153QUALAQUIN (QUININE SULFATE) CAPSULE [AR SCIENTIFIC INC.]16Legacy NDC, 4 package rows20130425_1f66fba7-4026-4504-918d-4c88f2835cc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997012Qualaquin 324 MG Oral CapsulePSN1f66fba7-4026-4504-918d-4c88f2835cc016
997010quiNINE sulfate 324 MG Oral CapsulePSN1f66fba7-4026-4504-918d-4c88f2835cc016
997012quinine sulfate 324 MG Oral Capsule [Qualaquin]SBD1f66fba7-4026-4504-918d-4c88f2835cc016
997010quinine sulfate 324 MG Oral CapsuleSCD1f66fba7-4026-4504-918d-4c88f2835cc016
997012Qualaquin 324 MG Oral CapsuleSY1f66fba7-4026-4504-918d-4c88f2835cc016
997012Qualaquin 324 MG Oral CapsulePSNce2ffee3-3048-43a0-ac45-ee32ce0c4c331
997010quiNINE sulfate 324 MG Oral CapsulePSNce2ffee3-3048-43a0-ac45-ee32ce0c4c331
997012quinine sulfate 324 MG Oral Capsule [Qualaquin]SBDce2ffee3-3048-43a0-ac45-ee32ce0c4c331
997010quinine sulfate 324 MG Oral CapsuleSCDce2ffee3-3048-43a0-ac45-ee32ce0c4c331
997012Qualaquin 324 MG Oral CapsuleSYce2ffee3-3048-43a0-ac45-ee32ce0c4c331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
13310-153-0113310015301100 in 1 BOTTLE, PLASTICHistorical
13310-153-0513310015305500 in 1 BOTTLE, PLASTICHistorical
13310-153-071331001530730 in 1 BOTTLE, PLASTICHistorical
13310-153-10133100153101000 in 1 BOTTLE, PLASTICHistorical