FDA.reportPublic FDA data

Loratadine

Product NDC
70010-162
11-digit product format
700100162
Labeler code
70010
Product ID
70010-162_346155e4-f155-2f14-e063-6294a90ac61f
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA210722
Marketing category
ANDA
Marketing start
2020-01-01
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
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
70010-162-01Loratadine100 in 1 BOTTLETABLET1005
70010-162-03Loratadine30 in 1 BOTTLETABLET305
70010-162-34Loratadine300 in 1 BOTTLETABLET3005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-162-01EA - Each70010-162590b49a0-7416-4a5b-9ef6-cdc10a4b3a3f12021-12-08
70010-162-34EA - Each70010-1629d40ed54-0327-411e-9606-1ffef0f56c9012022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-162LORATADINE TABLET [GRANULES PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20250508_d15add22-bc2d-9730-e053-2a95a90acd3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNd15add22-bc2d-9730-e053-2a95a90acd3f5
311372loratadine 10 MG Oral TabletSCDd15add22-bc2d-9730-e053-2a95a90acd3f5
311372loratadine 10 MG 24 HR Oral TabletSYd15add22-bc2d-9730-e053-2a95a90acd3f5
311372loratadine 10 MG 24HR Oral TabletPSN16f00a3a-0777-f70c-e063-6294a90a71c93
311372loratadine 10 MG 24HR Oral TabletPSNc6144a33-6b33-4aca-86e5-a3f688b8b3173
311372loratadine 10 MG Oral TabletSCD16f00a3a-0777-f70c-e063-6294a90a71c93
311372loratadine 10 MG Oral TabletSCDc6144a33-6b33-4aca-86e5-a3f688b8b3173
311372loratadine 10 MG 24 HR Oral TabletSY16f00a3a-0777-f70c-e063-6294a90a71c93
311372loratadine 10 MG 24 HR Oral TabletSYc6144a33-6b33-4aca-86e5-a3f688b8b3173
311372loratadine 10 MG 24HR Oral TabletPSNa5d54183-06a9-4ae1-93b9-e9a2e03ad42b2
311372loratadine 10 MG 24HR Oral TabletPSN2bc586e4-5297-44cf-e063-6294a90a531d2
311372loratadine 10 MG 24HR Oral TabletPSN0d74af21-3ef7-418b-a2ef-78737b0af2882
311372loratadine 10 MG Oral TabletSCDa5d54183-06a9-4ae1-93b9-e9a2e03ad42b2
311372loratadine 10 MG Oral TabletSCD0d74af21-3ef7-418b-a2ef-78737b0af2882
311372loratadine 10 MG Oral TabletSCD2bc586e4-5297-44cf-e063-6294a90a531d2
311372loratadine 10 MG 24 HR Oral TabletSYa5d54183-06a9-4ae1-93b9-e9a2e03ad42b2
311372loratadine 10 MG 24 HR Oral TabletSY2bc586e4-5297-44cf-e063-6294a90a531d2
311372loratadine 10 MG 24 HR Oral TabletSY0d74af21-3ef7-418b-a2ef-78737b0af2882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70010-162-0170010016201100 TABLET in 1 BOTTLE (70010-162-01) 100 tablet2021-11-170000-00-00NoNoCurrent
70010-162-037001001620330 TABLET in 1 BOTTLE (70010-162-03) 30 tablet2022-05-01NoNoHistorical
70010-162-3470010016234300 TABLET in 1 BOTTLE (70010-162-34) 300 tablet2022-05-010000-00-00NoNoCurrent