Allergy Relief

Product NDC
55315-741
11-digit product format
553150741
Labeler code
55315
Product ID
55315-741_f3ccc195-faa6-49b0-98c8-60aa5994f7b0
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Freds Inc
Application
ANDA207235
Marketing category
ANDA
Marketing start
2018-01-31
Marketing end
2025-01-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55315-741-252021-10-19C16284748780-1ba0f9c33-5d84-a910-e053-dadaa90a0b8524fc1038-52b0-4de5-9f4d-f73c8fc118b8
55315-741-252021-01-29C16284748780-1ba0f9c33-5d84-a910-e053-dadaa90a0b8524fc1038-52b0-4de5-9f4d-f73c8fc118b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55315-741-25553150741251 BOTTLE in 1 BOX (55315-741-25) > 25 CAPSULE in 1 BOTTLE1 bottle2018-01-310000-00-00NoNoCurrent