FDA.reportPublic FDA data

Loratadine and Pseudoephedrine Sulfate

Product NDC
15127-717
11-digit product format
151270717
Labeler code
15127
Product ID
15127-717_22389ba2-a1fe-4ea1-98a0-b08aa4179eb0
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine and Pseudoephedrine Sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Select Brand
Application
ANDA076557
Marketing category
ANDA
Marketing start
2004-11-17
Marketing end
0000-00-00
Substance
LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength
10 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15127-717-052020-01-31C16284748780-19d75b9d0-9361-f424-e053-dadaa90a57ceDrug Facts
15127-717-152020-01-31C16284748780-19d75b9d0-9361-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15127-717-05Loratadine and Pseudoephedrine Sulfate5 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE52
15127-717-15Loratadine and Pseudoephedrine Sulfate15 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE152

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
PSEUDOEPHEDRINE SULFATEACTIVE INGREDIENTY9DL7QPE6BLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ELORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
SHELLACINACTIVE INGREDIENT46N107B71OLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15127-717LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]2Legacy NDC, 2 package rows20121018_bce6a530-9557-4b83-bb4d-4b196af56d7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1117562pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral TabletPSNbce6a530-9557-4b83-bb4d-4b196af56d7f2
111756224 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral TabletSCDbce6a530-9557-4b83-bb4d-4b196af56d7f2
1117562loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral TabletSYbce6a530-9557-4b83-bb4d-4b196af56d7f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
15127-717-05151270717055 in 1 BLISTER PACKHistorical
15127-717-151512707171515 in 1 BLISTER PACKHistorical