Levocetirizine Dihydrochloride

Product NDC
70934-400
11-digit product format
709340400
Labeler code
70934
Product ID
70934-400_a15dab51-e061-a398-e053-2995a90af08a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA203646
Marketing category
ANDA
Marketing start
2019-06-25
Marketing end
0000-00-00
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-400-302023-01-25C16284748780-1d6a99b39-a18b-a426-e053-dadaa90af4c2a15daf94-f4a0-e5bd-e053-2a95a90acb34
70934-400-302022-01-28C16284748780-1d6a99b39-a18b-a426-e053-dadaa90af4c2a15daf94-f4a0-e5bd-e053-2a95a90acb34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-400-307093404003030 TABLET in 1 BOTTLE, PLASTIC (70934-400-30) 30 tablet2019-06-250000-00-00NoNoCurrent