Signature Care Allergy Relief D

Product NDC
21130-176
11-digit product format
211300176
Labeler code
21130
Product ID
21130-176_b2b17cc7-398f-4cd7-a319-9e2deeb83432
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl, Pseudoephedrine HCl
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Safeway
Application
ANDA077170
Marketing category
ANDA
Marketing start
2015-10-15
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
5 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21130-176-53EA - Each21130-1762f74eeea-1e8a-484e-9c80-cbf8d3567d7712015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOASIGNATURE CARE ALLERGY RELIEF D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [SAFEWAY]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSIGNATURE CARE ALLERGY RELIEF D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [SAFEWAY]1
CETIRIZINEACTIVE MOIETYYO7261ME24SIGNATURE CARE ALLERGY RELIEF D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [SAFEWAY]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSIGNATURE CARE ALLERGY RELIEF D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [SAFEWAY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIGNATURE CARE ALLERGY RELIEF D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [SAFEWAY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIGNATURE CARE ALLERGY RELIEF D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [SAFEWAY]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIGNATURE CARE ALLERGY RELIEF D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [SAFEWAY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIGNATURE CARE ALLERGY RELIEF D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [SAFEWAY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIGNATURE CARE ALLERGY RELIEF D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [SAFEWAY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIGNATURE CARE ALLERGY RELIEF D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [SAFEWAY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SIGNATURE CARE ALLERGY RELIEF D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [SAFEWAY]1
TALCINACTIVE INGREDIENT7SEV7J4R1USIGNATURE CARE ALLERGY RELIEF D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-176SIGNATURE CARE ALLERGY RELIEF D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [SAFEWAY]2Legacy NDC20191217_88bb6998-d148-4332-8d72-fd1203f0cb2f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-176-532113001765312 BLISTER PACK in 1 CARTON (21130-176-53) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK12 blister pack2018-09-120000-00-00NoNoCurrent
21130-176-622113001766224 BLISTER PACK in 1 CARTON (21130-176-62) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK24 blister pack2015-10-150000-00-00NoNoCurrent