Loratadine

Product NDC
69230-323
11-digit product format
692300323
Labeler code
69230
Product ID
69230-323_04d9c5a8-1f42-f7c0-e063-6294a90a92ae
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Camber Consumer Care Inc
Application
ANDA211718
Marketing category
ANDA
Marketing start
2023-07-28
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
69230-323-01Loratadine10 in 1 CARTONTABLET102
69230-323-10Loratadine1000 in 1 BOTTLETABLET10002
69230-323-30Loratadine30 in 1 BOTTLETABLET302
69230-323-30Loratadine1 in 1 CARTONTABLET12
69230-323-31Loratadine108 in 1 BOTTLETABLET1082
69230-323-31Loratadine1 in 1 CARTONTABLET12
69230-323-32Loratadine10 in 1 BLISTER PACKTABLET102
69230-323-33Loratadine1 in 1 CARTONTABLET12
69230-323-33Loratadine100 in 1 BOTTLETABLET1002
69230-323-34Loratadine300 in 1 BOTTLETABLET3002
69230-323-34Loratadine1 in 1 CARTONTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-323-30EA - Each69230-323201bb70e-fb9b-4500-b71b-0f6a81ae449612024-04-05
69230-323-33EA - Each69230-32309fff6b2-e4ce-4023-a5aa-e9130a7fc06712024-04-05
69230-323-34EA - Each69230-3236fb9ba44-5272-4816-918a-5e1b0ef886c112024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-323LORATADINE (LORATADINE) TABLET [CAMBER CONSUMER CARE INC]2Current NDC, 11 package rows20230910_d57da4bd-af37-414a-a50c-e80d2bb28314.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNd778c4d2-184a-4dc8-9351-66d81d0618f23
311372loratadine 10 MG Oral TabletSCDd778c4d2-184a-4dc8-9351-66d81d0618f23
311372loratadine 10 MG 24 HR Oral TabletSYd778c4d2-184a-4dc8-9351-66d81d0618f23
311372loratadine 10 MG 24HR Oral TabletPSNd57da4bd-af37-414a-a50c-e80d2bb283142
311372loratadine 10 MG Oral TabletSCDd57da4bd-af37-414a-a50c-e80d2bb283142
311372loratadine 10 MG 24 HR Oral TabletSYd57da4bd-af37-414a-a50c-e80d2bb283142
311372loratadine 10 MG 24HR Oral TabletPSN52581dd2-9597-35cb-e063-6294a90a36c71
311372loratadine 10 MG 24HR Oral TabletPSN7f97595b-9df7-4834-82f0-5e4ce329c1181
311372loratadine 10 MG 24HR Oral TabletPSNbaad51cd-daa0-4920-a6d5-2faaaaea79561
311372loratadine 10 MG Oral TabletSCD52581dd2-9597-35cb-e063-6294a90a36c71
311372loratadine 10 MG Oral TabletSCD7f97595b-9df7-4834-82f0-5e4ce329c1181
311372loratadine 10 MG Oral TabletSCDbaad51cd-daa0-4920-a6d5-2faaaaea79561
311372loratadine 10 MG 24 HR Oral TabletSY52581dd2-9597-35cb-e063-6294a90a36c71
311372loratadine 10 MG 24 HR Oral TabletSY7f97595b-9df7-4834-82f0-5e4ce329c1181
311372loratadine 10 MG 24 HR Oral TabletSYbaad51cd-daa0-4920-a6d5-2faaaaea79561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69230-323-016923003230110 BLISTER PACK in 1 CARTON (69230-323-01) / 10 TABLET in 1 BLISTER PACK (69230-323-32) 10 blister pack2023-07-28NoNoCurrent
69230-323-10692300323101000 TABLET in 1 BOTTLE (69230-323-10) 1000 tablet2023-07-28NoNoCurrent
69230-323-30692300323301 BOTTLE in 1 CARTON (69230-323-30) / 30 TABLET in 1 BOTTLE1 bottle2023-07-28NoNoCurrent
69230-323-31692300323311 BOTTLE in 1 CARTON (69230-323-31) / 108 TABLET in 1 BOTTLE1 bottle2023-07-28NoNoCurrent
69230-323-326923003233210 in 1 BLISTER PACKHistorical
69230-323-33692300323331 BOTTLE in 1 CARTON (69230-323-33) / 100 TABLET in 1 BOTTLE1 bottle2023-07-28NoNoCurrent
69230-323-34692300323341 BOTTLE in 1 CARTON (69230-323-34) / 300 TABLET in 1 BOTTLE1 bottle2023-07-28NoNoCurrent