Cetirizine Hydrochloride

Product NDC
53002-1259
11-digit product format
530021259
Labeler code
53002
Product ID
53002-1259_880775db-061e-4282-bc19-fe651dd86ce3
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA077829
Marketing category
ANDA
Marketing start
2009-10-01
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
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
53002-1259-02023-11-07C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-12023-11-07C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-22023-11-07C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-32023-11-07C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-92023-11-07C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-02023-01-30C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-12023-01-30C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-22023-01-30C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-32023-01-30C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-92023-01-30C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-02020-12-15C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-12020-12-15C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-22020-12-15C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-32020-12-15C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-92020-12-15C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-02020-01-31C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-12020-01-31C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-22020-01-31C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-32020-01-31C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c
53002-1259-92020-01-31C16284748780-19d75b9d0-6f4f-f424-e053-dadaa90a57cefe3b3628-38f2-4685-9863-f06a0643a75c

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1259-053002125900100 TABLET in 1 BOTTLE (53002-1259-0) 100 tablet2017-09-010000-00-00NoNoCurrent
53002-1259-15300212590110 TABLET in 1 BOTTLE (53002-1259-1) 10 tablet2017-09-010000-00-00NoNoCurrent
53002-1259-25300212590220 TABLET in 1 BOTTLE (53002-1259-2) 20 tablet2017-09-010000-00-00NoNoCurrent
53002-1259-35300212590330 TABLET in 1 BOTTLE (53002-1259-3) 30 tablet2017-09-010000-00-00NoNoCurrent
53002-1259-9530021259095 TABLET in 1 BOTTLE (53002-1259-9) 5 tablet2017-09-010000-00-00NoNoCurrent