FDA.reportPublic FDA data

Leader Allergy Relief D-24

Product NDC
70000-0162
11-digit product format
700000162
Labeler code
70000
Product ID
70000-0162_2aa29226-da73-4113-9dbd-ed13b345464d
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine and Pseudoephedrine Sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health
Application
ANDA076557
Marketing category
ANDA
Marketing start
2017-02-15
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
Leader Allergy Relief D-24
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
70000-0162-1Leader Allergy Relief D-2410 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE104
70000-0162-2Leader Allergy Relief D-2415 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0162-1EA - Each70000-01626e30aa40-870a-4bad-84de-363b6910ee9712017-12-14
70000-0162-2EA - Each70000-01624f5c4e66-8076-41bb-9f08-5cafe168067b12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0162LEADER ALLERGY RELIEF D-24 (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]4Current NDC, Legacy NDC, 2 package rows20220323_f1bcd2aa-e8cd-4364-87b4-c544537cdb50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1117562pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral TabletPSNf1bcd2aa-e8cd-4364-87b4-c544537cdb504
111756224 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral TabletSCDf1bcd2aa-e8cd-4364-87b4-c544537cdb504
1117562loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral TabletSYf1bcd2aa-e8cd-4364-87b4-c544537cdb504

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0162-17000001620110 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70000-0162-1) 2020-01-150000-00-00NoNoCurrent
70000-0162-27000001620215 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70000-0162-2) 2020-01-150000-00-00NoNoCurrent