FDA.reportPublic FDA data

Loratadine and Pseudoephedrine

Product NDC
63187-305
11-digit product format
631870305
Labeler code
63187
Product ID
63187-305_4b42b2f4-a013-4b16-bc3e-d9c3b503beed
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine and pseudoephedrine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076557
Marketing category
ANDA
Marketing start
2004-11-17
Substance
LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength
10; 240 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine and Pseudoephedrine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1
PSEUDOEPHEDRINE SULFATE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN, Y9DL7QPE6B
Rxcui1117562

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-305-10Loratadine and Pseudoephedrine1 in 1 CARTONTABLET, EXTENDED RELEASE12
63187-305-10Loratadine and Pseudoephedrine10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
PSEUDOEPHEDRINE SULFATEACTIVE INGREDIENTY9DL7QPE6BLORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FLORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKLORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ELORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
SHELLACINACTIVE INGREDIENT46N107B71OLORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRLORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-305LORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 2 package rows20191211_ca1a6552-d082-4312-ba17-0055e8554eb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1117562pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral TabletPSNca1a6552-d082-4312-ba17-0055e8554eb92
111756224 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral TabletSCDca1a6552-d082-4312-ba17-0055e8554eb92
1117562loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral TabletSYca1a6552-d082-4312-ba17-0055e8554eb92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-305-10631870305101 BLISTER PACK in 1 CARTON (63187-305-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2015-03-010000-00-00NoNoCurrent