FDA.reportPublic FDA data

Allergy relief-D

Product NDC
49035-982
11-digit product format
490350982
Labeler code
49035
Product ID
49035-982_ef4fc264-bf2e-404d-95a0-ff92ed0bc347
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
EQUATE (WAL-MART STORES, INC.)
Application
ANDA090922
Marketing category
ANDA
Marketing start
2019-05-31
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-982-242021-01-29C16284748780-1ba0f9c33-44ca-a910-e053-dadaa90a0b85Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-982-24Allergy relief-D6 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE62
49035-982-24Allergy relief-D4 in 1 CARTONTABLET, FILM COATED, EXTENDED RE42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-982-24EA - Each49035-9822336183e-dd6b-4924-a9b4-1463e68fe2e212023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-982ALLERGY RELIEF-D (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [EQUATE (WAL-MART STORES, INC.)]2Legacy NDC, 2 package rows20190531_325975c2-9f88-4500-a620-deb419f1f35c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014571cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN325975c2-9f88-4500-a620-deb419f1f35c2
101457112 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD325975c2-9f88-4500-a620-deb419f1f35c2
1014571cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY325975c2-9f88-4500-a620-deb419f1f35c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49035-982-24490350982246 in 1 BLISTER PACKHistorical