kirkland signature aller tec d

Product NDC
63981-147
11-digit product format
639810147
Labeler code
63981
Product ID
63981-147_597ad0d6-abb0-47c1-b9f6-bc37e2968a69
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride, pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Costco Wholesale Company
Application
ANDA210719
Marketing category
ANDA
Marketing start
2020-03-30
Substance
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
5; 120 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 aller tec d
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA, 6V9V2RYJ8N
Rxcui1014571, 1014573

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
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
63981-147-62kirkland signature aller tec d1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE15
63981-147-62kirkland signature aller tec d24 in 1 CARTONTABLET, FILM COATED, EXTENDED RE245

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-147-62EA - Each63981-1478e460ce5-d1a8-46b1-95d2-25a85dc3c9d612020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-147KIRKLAND SIGNATURE ALLER TEC D (CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [COSTCO WHOLESALE COMPANY]5Current NDC, Legacy NDC, 2 package rows20250216_a8e57b21-4622-4315-8e8e-437243be2fe1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014573ALLER-TEC D ALLERGY & CONGESTION 5 MG / 120 MG 12HR Extended Release Oral TabletPSNa8e57b21-4622-4315-8e8e-437243be2fe15
1014571cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNa8e57b21-4622-4315-8e8e-437243be2fe15
101457312 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Aller-Tec D]SBDa8e57b21-4622-4315-8e8e-437243be2fe15
101457112 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDa8e57b21-4622-4315-8e8e-437243be2fe15
1014573Aller-Tec D (cetirizine dihydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG) 12 HR Extended Release Oral TabletSYa8e57b21-4622-4315-8e8e-437243be2fe15
1014571cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYa8e57b21-4622-4315-8e8e-437243be2fe15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63981-147-626398101476224 BLISTER PACK in 1 CARTON (63981-147-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK24 blister pack2020-03-300000-00-00NoNoCurrent