LORATADINE

Product NDC
59556-301
11-digit product format
595560301
Labeler code
59556
Product ID
59556-301_0df121d3-d783-620c-e063-6294a90acdab
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Inc
Application
ANDA212795
Marketing category
ANDA
Marketing start
2021-08-10
Substance
LORATADINE
Active strength
5 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
LORATADINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui672558

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59556-301-01LORATADINE10 in 1 BLISTER PACKTABLET109
59556-301-01LORATADINE1 in 1 CARTONTABLET19
59556-301-02LORATADINE10 in 1 BLISTER PACKTABLET109
59556-301-02LORATADINE2 in 1 CARTONTABLET29
59556-301-03LORATADINE3 in 1 CARTONTABLET39
59556-301-03LORATADINE10 in 1 BLISTER PACKTABLET109
59556-301-04LORATADINE10 in 1 BLISTER PACKTABLET109
59556-301-04LORATADINE4 in 1 CARTONTABLET49
59556-301-05LORATADINE10 in 1 BLISTER PACKTABLET109
59556-301-05LORATADINE5 in 1 CARTONTABLET59
59556-301-06LORATADINE10 in 1 BLISTER PACKTABLET109
59556-301-06LORATADINE6 in 1 CARTONTABLET69

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59556-301LORATADINE TABLET [STRIDES PHARMA INC]9Current NDC, Legacy NDC, 12 package rows20240102_a54cdbe9-32ec-45ca-948f-9cefbb8e3cbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
672558loratadine 5 MG Disintegrating Oral TabletPSNa54cdbe9-32ec-45ca-948f-9cefbb8e3cbf9
672558loratadine 5 MG Disintegrating Oral TabletSCDa54cdbe9-32ec-45ca-948f-9cefbb8e3cbf9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59556-301-01595560301011 BLISTER PACK in 1 CARTON (59556-301-01) / 10 TABLET in 1 BLISTER PACK1 blister pack2021-08-100000-00-00NoNoCurrent
59556-301-02595560301022 BLISTER PACK in 1 CARTON (59556-301-02) / 10 TABLET in 1 BLISTER PACK2 blister pack2021-08-100000-00-00NoNoCurrent
59556-301-03595560301033 BLISTER PACK in 1 CARTON (59556-301-03) / 10 TABLET in 1 BLISTER PACK3 blister pack2021-08-100000-00-00NoNoCurrent
59556-301-04595560301044 BLISTER PACK in 1 CARTON (59556-301-04) / 10 TABLET in 1 BLISTER PACK4 blister pack2021-08-100000-00-00NoNoCurrent
59556-301-05595560301055 BLISTER PACK in 1 CARTON (59556-301-05) / 10 TABLET in 1 BLISTER PACK5 blister pack2021-08-100000-00-00NoNoCurrent
59556-301-06595560301066 BLISTER PACK in 1 CARTON (59556-301-06) / 10 TABLET in 1 BLISTER PACK6 blister pack2021-08-100000-00-00NoNoCurrent