FDA.reportPublic FDA data

Loratadine and Pseudoephedrine

Product NDC
41163-165
11-digit product format
411630165
Labeler code
41163
Product ID
41163-165_7320124e-4f2f-4fbc-9ccd-d39400919ccd
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine and Pseudoephedrine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
SUPERVALU INC.
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
41163-165-522020-01-31C16284748780-19d75b9d0-ba49-f424-e053-dadaa90a57ceLoratadine and Pseudoephedrine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-165-52Loratadine and Pseudoephedrine10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-165-52EA - Each41163-16550816a80-c5c8-4be0-b2e6-419ee2db92fb12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
PSEUDOEPHEDRINE SULFATEACTIVE INGREDIENTY9DL7QPE6BLORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FLORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKLORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OLORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRLORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-165LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]2Legacy NDC, 1 package rows20180824_3e581cf0-21a0-46ff-a9ed-85b06e64c9ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1117562pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral TabletPSN3e581cf0-21a0-46ff-a9ed-85b06e64c9ec2
111756224 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral TabletSCD3e581cf0-21a0-46ff-a9ed-85b06e64c9ec2
1117562loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral TabletSY3e581cf0-21a0-46ff-a9ed-85b06e64c9ec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
41163-165-524116301655210 in 1 BLISTER PACKHistorical