FDA.reportPublic FDA data

equate allergy relief

Product NDC
49035-612
11-digit product format
490350612
Labeler code
49035
Product ID
49035-612_ee35ff28-273b-4264-bef1-4a759d86a8be
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA076301
Marketing category
ANDA
Marketing start
2007-04-27
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
equate allergy relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-612-46equate allergy relief1 in 1 BLISTER PACKTABLET16
49035-612-46equate allergy relief10 in 1 CARTONTABLET106
49035-612-47equate allergy relief150 in 1 BOTTLETABLET1506
49035-612-65equate allergy relief1 in 1 CARTONTABLET16
49035-612-65equate allergy relief30 in 1 BOTTLETABLET306
49035-612-72equate allergy relief1 in 1 CARTONTABLET16
49035-612-72equate allergy relief60 in 1 BOTTLETABLET606
49035-612-76equate allergy relief2 in 1 CARTONTABLET26
49035-612-76equate allergy relief60 in 1 BOTTLETABLET606
49035-612-87equate allergy relief150 in 1 BOTTLETABLET1506
49035-612-87equate allergy relief2 in 1 PACKAGETABLET26
49035-612-95equate allergy relief45 in 1 BOTTLETABLET456
49035-612-95equate allergy relief1 in 1 CARTONTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-612-46EA - Each49035-61218ebb144-f1d5-4947-b996-1ea5dce89e4812013-06-04
49035-612-47EA - Each49035-6127fb018e3-9d4e-4894-a107-08b19a60b71612016-10-06
49035-612-65EA - Each49035-6124e99466b-2442-4536-8911-91754998060f12013-06-04
49035-612-72EA - Each49035-612511d5401-7718-40a3-b1cb-a418f1c0a35212012-07-24
49035-612-76EA - Each49035-61273b2f6b9-ce43-410e-b9fe-b489cde2ba3712022-06-06
49035-612-87EA - Each49035-612fa475230-c9cb-4f76-a707-81729989b10212021-11-09
49035-612-95EA - Each49035-6123d05874e-2e18-4a5c-b582-eda865cba4da12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNEQUATE ALLERGY RELIEF (LORATADINE) TABLET [WAL-MART STORES INC]4
LORATADINEACTIVE MOIETY7AJO3BO7QNEQUATE ALLERGY RELIEF (LORATADINE) TABLET [WAL-MART STORES INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEQUATE ALLERGY RELIEF (LORATADINE) TABLET [WAL-MART STORES INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EQUATE ALLERGY RELIEF (LORATADINE) TABLET [WAL-MART STORES INC]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EEQUATE ALLERGY RELIEF (LORATADINE) TABLET [WAL-MART STORES INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-612EQUATE ALLERGY RELIEF (LORATADINE) TABLET [WAL-MART STORES INC]6Current NDC, Legacy NDC, 13 package rows20221206_dd36dc43-a9b7-4cda-86e0-9283d996a60a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNdd36dc43-a9b7-4cda-86e0-9283d996a60a6
311372loratadine 10 MG Oral TabletSCDdd36dc43-a9b7-4cda-86e0-9283d996a60a6
311372loratadine 10 MG 24 HR Oral TabletSYdd36dc43-a9b7-4cda-86e0-9283d996a60a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-612-464903506124610 BLISTER PACK in 1 CARTON (49035-612-46) / 1 TABLET in 1 BLISTER PACK10 blister pack2012-02-280000-00-00NoNoCurrent
49035-612-4749035061247150 TABLET in 1 BOTTLE (49035-612-47) 150 tablet2012-03-010000-00-00NoNoCurrent
49035-612-65490350612651 BOTTLE in 1 CARTON (49035-612-65) > 30 TABLET in 1 BOTTLE1 bottle2012-02-290000-00-00NoNoCurrent
49035-612-72490350612721 BOTTLE in 1 CARTON (49035-612-72) / 60 TABLET in 1 BOTTLE1 bottle2007-04-270000-00-00NoNoCurrent
49035-612-76490350612762 BOTTLE in 1 CARTON (49035-612-76) > 60 TABLET in 1 BOTTLE2 bottle2015-02-030000-00-00NoNoCurrent
49035-612-87490350612872 BOTTLE in 1 PACKAGE (49035-612-87) / 150 TABLET in 1 BOTTLE2 bottle2012-03-010000-00-00NoNoCurrent
49035-612-95490350612951 BOTTLE in 1 CARTON (49035-612-95) / 45 TABLET in 1 BOTTLE1 bottle2013-08-200000-00-00NoNoCurrent