Loratadine ODT

Product NDC
49035-806
11-digit product format
490350806
Labeler code
49035
Product ID
49035-806_3b02a6a4-b8f8-43b4-bf82-f5fd0007643f
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Wal-Mart Stores, Inc.
Application
ANDA208477
Marketing category
ANDA
Marketing start
2018-04-11
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
Loratadine ODT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311373

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-806-09Loratadine ODT3 in 1 CARTONTABLET, ORALLY DISINTEGRATING34
49035-806-09Loratadine ODT10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING104
49035-806-03Loratadine ODT1 in 1 CARTONTABLET, ORALLY DISINTEGRATING13
49035-806-03Loratadine ODT10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-806-03EA - Each49035-80629bc985c-e772-4aca-aede-61203edfa06512025-07-08
49035-806-09EA - Each49035-80682f9ee1c-b48a-40da-9eb3-a718601822af12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-806LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [WAL-MART STORES, INC.]4Current NDC, Legacy NDC, 2 package rows20221108_f399f7ab-ab51-46ff-bce9-3014eb021930.zip
49035-806LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [WAL-MART STORES, INC.]3Current NDC, Legacy NDC, 2 package rows20250130_7679ee14-08aa-459c-9107-1a7144379962.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSNf399f7ab-ab51-46ff-bce9-3014eb0219304
311373loratadine 10 MG Disintegrating Oral TabletSCDf399f7ab-ab51-46ff-bce9-3014eb0219304
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN7679ee14-08aa-459c-9107-1a71443799623
311373loratadine 10 MG Disintegrating Oral TabletSCD7679ee14-08aa-459c-9107-1a71443799623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-806-03490350806031 BLISTER PACK in 1 CARTON (49035-806-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2018-04-110000-00-00NoNoCurrent
49035-806-09490350806093 BLISTER PACK in 1 CARTON (49035-806-09) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2018-04-110000-00-00NoNoCurrent