Home NDC 40032-652-30 Cetirizine Hydrochloride
Product NDC 40032-652
Requested package NDC 40032-652-30
11-digit product format 400320652
Labeler code 40032
Product ID 40032-652_9a2d773a-3076-84c5-e053-2995a90a5864
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Novel Laboratories, Inc.
Application ANDA206793
Marketing category ANDA
Marketing start 2016-03-08
Marketing end 0000-00-00
Substance CETIRIZINE HYDROCHLORIDE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2016-03-08 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2016-03-08
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 40032-652-03 Cetirizine Hydrochloride 1 in 1 CARTON TABLET, CHEWABLE 1 4 40032-652-03 Cetirizine Hydrochloride 30 in 1 BOTTLE TABLET, CHEWABLE 30 4 40032-652-10 Cetirizine Hydrochloride 1000 in 1 BOTTLE TABLET, CHEWABLE 1000 4 40032-652-30 Cetirizine Hydrochloride 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 4 40032-652-30 Cetirizine Hydrochloride 3 in 1 CARTON TABLET, CHEWABLE 3 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40032-652 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [NOVEL LABORATORIES, INC.] 4 Legacy NDC, 5 package rows 20191221_c6a339dc-d56a-49d9-bf74-af54d2ba9b3c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 40032-652-30 40032065230 3 BLISTER PACK in 1 CARTON (40032-652-30) > 10 TABLET, CHEWABLE in 1 BLISTER PACK 3 blister pack 2016-03-08 0000-00-00 No No Current