Allergy relief

Product NDC
57896-658
11-digit product format
578960658
Labeler code
57896
Product ID
57896-658_3affa084-e277-35a9-e063-6294a90a9151
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
ANDA075209
Marketing category
ANDA
Marketing start
2020-02-01
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
Allergy relief
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57896-658-032022-11-22C16284748780-1d6a99b39-b509-a426-e053-dadaa90af4c2788S (658)
57896-658-092022-11-22C16284748780-1d6a99b39-b509-a426-e053-dadaa90af4c2788S (658)
57896-658-032022-01-28C16284748780-1d6a99b39-b509-a426-e053-dadaa90af4c2788S (658)
57896-658-092022-01-28C16284748780-1d6a99b39-b509-a426-e053-dadaa90af4c2788S (658)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-658-03Allergy relief30 in 1 BOTTLETABLET304
57896-658-09Allergy relief90 in 1 BOTTLETABLET904
57896-658-36Allergy relief365 in 1 BOTTLETABLET3654

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-658-03EA - Each57896-65868d4cd4a-0106-45bc-bdb5-e1c18b355e9512022-03-09
57896-658-09EA - Each57896-6581b15dde2-c586-4c46-a621-5729663b7fc712022-03-09
57896-658-36EA - Each57896-658875757b6-7b45-4cee-a29b-2f35aa21f13312024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-658ALLERGY RELIEF (LORATADINE) TABLET [GERI-CARE PHARMACEUTICAL CORP]3Current NDC, Legacy NDC, 3 package rows20241218_b66f171a-7b95-b27a-e053-2a95a90a6009.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNe87aa69c-9ec6-482d-8e28-32542f6b9166101
311372loratadine 10 MG Oral TabletSCDe87aa69c-9ec6-482d-8e28-32542f6b9166101
311372loratadine 10 MG 24 HR Oral TabletSYe87aa69c-9ec6-482d-8e28-32542f6b9166101
311372loratadine 10 MG 24HR Oral TabletPSN210fa77a-e33e-48c4-8228-b1cf3ccb7fa48
311372loratadine 10 MG Oral TabletSCD210fa77a-e33e-48c4-8228-b1cf3ccb7fa48
311372loratadine 10 MG 24 HR Oral TabletSY210fa77a-e33e-48c4-8228-b1cf3ccb7fa48
311372loratadine 10 MG 24HR Oral TabletPSNb66f171a-7b95-b27a-e053-2a95a90a60094
311372loratadine 10 MG Oral TabletSCDb66f171a-7b95-b27a-e053-2a95a90a60094
311372loratadine 10 MG 24 HR Oral TabletSYb66f171a-7b95-b27a-e053-2a95a90a60094
311372loratadine 10 MG 24HR Oral TabletPSNc0e3057d-2dd2-de2b-e053-2995a90a1a1d2
311372loratadine 10 MG Oral TabletSCDc0e3057d-2dd2-de2b-e053-2995a90a1a1d2
311372loratadine 10 MG 24 HR Oral TabletSYc0e3057d-2dd2-de2b-e053-2995a90a1a1d2
311372loratadine 10 MG 24HR Oral TabletPSN836f566c-0296-408a-ad2a-6a77e18552181
311372loratadine 10 MG Oral TabletSCD836f566c-0296-408a-ad2a-6a77e18552181
311372loratadine 10 MG 24 HR Oral TabletSY836f566c-0296-408a-ad2a-6a77e18552181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-658-035789606580330 TABLET in 1 BOTTLE (57896-658-03) 30 tablet2020-02-010000-00-00NoNoCurrent
57896-658-095789606580990 TABLET in 1 BOTTLE (57896-658-09) 90 tablet2020-02-010000-00-00NoNoCurrent
57896-658-3657896065836365 TABLET in 1 BOTTLE (57896-658-36) 365 tablet2022-04-010000-00-00NoNoCurrent