Childrens Loratadine

Product NDC
0121-0849
11-digit product format
001210849
Labeler code
0121
Product ID
0121-0849_ed84fb8c-15cf-3179-e053-2a95a90ab5b4
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA077421
Marketing category
ANDA
Marketing start
2010-11-24
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0121-0849-402022-11-15C16284748780-1d6a99b39-d063-a426-e053-dadaa90af4c264112220-8b9b-4871-9d6e-67ee1677acab
0121-0849-402022-01-28C16284748780-1d6a99b39-d063-a426-e053-dadaa90af4c264112220-8b9b-4871-9d6e-67ee1677acab

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0849-10ML - Milliliter0121-0849da134817-bdb6-4cb5-b6b7-8f8db9c4e8e912018-10-11
0121-0849-40ML - Milliliter0121-084901ca2595-80b6-4a96-b835-682669af37b612018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0849-40001210849404 TRAY in 1 CASE (0121-0849-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-0849-10) 4 tray2018-05-280000-00-00NoNoCurrent