Handy Solutions 24 Hour Allergy

Product NDC
67751-163
11-digit product format
677510163
Labeler code
67751
Product ID
67751-163_f6f7b483-e260-2138-e053-6394a90ae319
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
ANDA076134
Marketing category
ANDA
Marketing start
2016-09-22
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Handy Solutions 24 Hour Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-163-01Handy Solutions 24 Hour Allergy1 in 1 CARTONTABLET, FILM COATED13
67751-163-01Handy Solutions 24 Hour Allergy6 in 1 POUCHTABLET, FILM COATED63
67751-163-02Handy Solutions 24 Hour Allergy1 in 1 CARTONTABLET, FILM COATED13
67751-163-02Handy Solutions 24 Hour Allergy2 in 1 POUCHTABLET, FILM COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-163HANDY SOLUTIONS 24 HOUR ALLERGY (LORATADINE) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]3Current NDC, Legacy NDC, 4 package rows20230316_67263031-9095-48f2-8b34-e589b28a7416.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN67263031-9095-48f2-8b34-e589b28a74163
311372loratadine 10 MG Oral TabletSCD67263031-9095-48f2-8b34-e589b28a74163
311372loratadine 10 MG 24 HR Oral TabletSY67263031-9095-48f2-8b34-e589b28a74163

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-163-01677510163011 POUCH in 1 CARTON (67751-163-01) / 6 TABLET, FILM COATED in 1 POUCH1 pouch2016-09-220000-00-00NoNoCurrent
67751-163-02677510163021 POUCH in 1 CARTON (67751-163-02) / 2 TABLET, FILM COATED in 1 POUCH1 pouch2016-09-220000-00-00NoNoCurrent