Allergy Relief

Product NDC
55315-806
11-digit product format
553150806
Labeler code
55315
Product ID
55315-806_b0458063-a6ce-483d-8736-3fde8cf07d5c
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Freds Inc
Application
ANDA209274
Marketing category
ANDA
Marketing start
2019-02-28
Marketing end
2025-02-28
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55315-806-05553150806055 BLISTER PACK in 1 CARTON (55315-806-05) > 1 TABLET in 1 BLISTER PACK5 blister pack2019-02-282025-02-28NoNoCurrent