betr remedies all day allergy relief

Product NDC
80267-409
11-digit product format
802670409
Labeler code
80267
Product ID
80267-409_4a017852-db01-4085-8947-d92a19ec4e5c
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Live Betr LLC
Application
ANDA078336
Marketing category
ANDA
Marketing start
2023-05-10
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
betr remedies all day allergy relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80267-409-95betr remedies all day allergy relief45 in 1 BOTTLETABLET, FILM COATED451
80267-409-95betr remedies all day allergy relief1 in 1 CARTONTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80267-409BETR REMEDIES ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [LIVE BETR LLC]1Current NDC, 2 package rows20230519_4a017852-db01-4085-8947-d92a19ec4e5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN4a017852-db01-4085-8947-d92a19ec4e5c1
1014678cetirizine hydrochloride 10 MG Oral TabletSCD4a017852-db01-4085-8947-d92a19ec4e5c1
1014678cetirizine HCl 10 MG Oral TabletSY4a017852-db01-4085-8947-d92a19ec4e5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80267-409-95802670409951 BOTTLE in 1 CARTON (80267-409-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-05-10NoNoCurrent