kirkland signature allerclear d 12 hr

Product NDC
63981-723
11-digit product format
639810723
Labeler code
63981
Product ID
63981-723_24d75860-d636-416a-b89f-4b503c526802
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine, Pseudoephedrine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Costco Wholesale Company
Application
ANDA076050
Marketing category
ANDA
Marketing start
2018-05-07
Substance
LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength
5; 120 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
kirkland signature allerclear d 12 hr
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/1
PSEUDOEPHEDRINE SULFATE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN, Y9DL7QPE6B
Rxcui1242399, 1369753

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
63981-723-65kirkland signature allerclear d 12 hr30 in 1 CARTONTABLET, FILM COATED, EXTENDED RE304
63981-723-65kirkland signature allerclear d 12 hr1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-723-65EA - Each63981-72304fae382-a322-42e0-8cff-f66fac39428612018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-723KIRKLAND SIGNATURE ALLERCLEAR D 12 HR (LORATADINE, PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [COSTCO WHOLESALE COMPANY]4Current NDC, Legacy NDC, 2 package rows20230719_1534720b-f8f8-4db5-99e0-cfa49acf9299.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1369753AllerClear-D 5 MG / 120 MG 12HR Extended Release Oral TabletPSN1534720b-f8f8-4db5-99e0-cfa49acf92994
1242399pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral TabletPSN1534720b-f8f8-4db5-99e0-cfa49acf92994
136975312 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet [Allerclear]SBD1534720b-f8f8-4db5-99e0-cfa49acf92994
124239912 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral TabletSCD1534720b-f8f8-4db5-99e0-cfa49acf92994
1369753AllerClear (loratadine 5 MG / pseudoephedrine sulfate 120 MG) 12 HR Extended Release Oral TabletSY1534720b-f8f8-4db5-99e0-cfa49acf92994
1242399loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral TabletSY1534720b-f8f8-4db5-99e0-cfa49acf92994

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63981-723-656398107236530 BLISTER PACK in 1 CARTON (63981-723-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK30 blister pack2018-05-070000-00-00NoNoCurrent