allergy

Product NDC
0904-5728
11-digit product format
009045728
Labeler code
0904
Product ID
0904-5728_7a54ad35-6400-4ba3-97f9-58db3e46cdcd
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA076301
Marketing category
ANDA
Marketing start
2005-02-21
Marketing end
2021-02-28
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5728-15EA - Each0904-5728872ad63e-9184-4804-ab9f-33a2a0dd78a612013-02-13
0904-5728-72EA - Each0904-572858eebf50-d300-418a-ac65-06ec0d1647b112018-10-11
0904-5728-87EA - Each0904-572848bdcfe2-89b5-49c2-af00-cb8e4d24388712013-02-13
0904-5728-89EA - Each0904-5728a91d1a69-fdf3-4942-a625-443c96be8f8a12013-02-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNabcb1ea1-8244-4818-9f73-17ffb8e21d743
311372loratadine 10 MG Oral TabletSCDabcb1ea1-8244-4818-9f73-17ffb8e21d743
311372loratadine 10 MG 24 HR Oral TabletSYabcb1ea1-8244-4818-9f73-17ffb8e21d743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5728-72009045728721 BOTTLE in 1 CARTON (0904-5728-72) > 300 TABLET in 1 BOTTLE1 bottle2018-04-252021-02-28NoNoCurrent
0904-5728-89009045728891 BOTTLE in 1 CARTON (0904-5728-89) > 90 TABLET in 1 BOTTLE1 bottle2005-03-312021-02-28NoNoCurrent