Home NDC 40032-653 Cetirizine Hydrochloride
Product NDC 40032-653
11-digit product format 400320653
Labeler code 40032
Product ID 40032-653_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 5 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 40032-653-03 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 40032-653-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 40032-653-10 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 40032-653-03 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 40032-653-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 40032-653-10 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 40032-653-03 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 40032-653-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 40032-653-10 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 40032-653-03 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 40032-653-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 40032-653-10 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 40032-653-03 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 40032-653-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 40032-653-10 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 40032-653-03 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 40032-653-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 40032-653-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 40032-653-10 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 40032-653-03 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 40032-653-30 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 40032-653-10 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 40032-653-03 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 40032-653-30 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 40032-653-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 40032-653-03 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 40032-653-30 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 3 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 2022-09-29 23:25 UTC 2022-09 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 e64feba35796…2022-09-29 23:25 UTC 2022-09 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206793-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2016-03-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206793-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2016-03-08 a50c72e98297…
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 40032-653-03 Cetirizine Hydrochloride 30 in 1 BOTTLE TABLET, CHEWABLE 30 4 40032-653-03 Cetirizine Hydrochloride 1 in 1 CARTON TABLET, CHEWABLE 1 4 40032-653-10 Cetirizine Hydrochloride 1000 in 1 BOTTLE TABLET, CHEWABLE 1000 4 40032-653-30 Cetirizine Hydrochloride 3 in 1 CARTON TABLET, CHEWABLE 3 4 40032-653-30 Cetirizine Hydrochloride 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40032-653 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 40032-653-03 40032065303 1 BOTTLE in 1 CARTON (40032-653-03) > 30 TABLET, CHEWABLE in 1 BOTTLE 1 bottle 2016-03-08 0000-00-00 No No Current 40032-653-10 40032065310 1000 TABLET, CHEWABLE in 1 BOTTLE (40032-653-10) 2016-03-08 0000-00-00 No No Current 40032-653-30 40032065330 3 BLISTER PACK in 1 CARTON (40032-653-30) > 10 TABLET, CHEWABLE in 1 BLISTER PACK 3 blister pack 2016-03-08 0000-00-00 No No Current