Home NDC 65162-046 Cetirizine Hydrochloride
Product NDC 65162-046
11-digit product format 651620046
Labeler code 65162
Product ID 65162-046_769059cb-864d-4fc7-8637-ca644c5874f4
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA078780
Marketing category ANDA
Marketing start 2010-01-21
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 2027-12-31
Current FDA listing Yes 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 · 33 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 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 65162-046-03 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 65162-046-50 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 65162-046-03 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 65162-046-50 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 65162-046-03 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 65162-046-50 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 65162-046-03 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 65162-046-50 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 65162-046-03 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 65162-046-50 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 65162-046-03 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 65162-046-50 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 65162-046-03 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 65162-046-50 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 65162-046-03 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 65162-046-50 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 65162-046-03 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 65162-046-50 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 65162-046-03 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 65162-046-50 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 65162-046-03 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 65162-046-50 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078780-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2010-01-21 A078780-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-01-21 A078780-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2010-01-21 A078780-004 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-01-21
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 5 · 176 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 2026-10-15 13:18:30 2026-09 A078780-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078780-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2010-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078780-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2010-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078780-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-01-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078780-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078780-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2010-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078780-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2010-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078780-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-01-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078780-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078780-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2010-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078780-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2010-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078780-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-01-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078780-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078780-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2010-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078780-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2010-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078780-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078780-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078780-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2010-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078780-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2010-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078780-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-01-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078780-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078780-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2010-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078780-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2010-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078780-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-01-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078780-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078780-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2010-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078780-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2010-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078780-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-01-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078780-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078780-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2010-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078780-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2010-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078780-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-01-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078780-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078780-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2010-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078780-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2010-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078780-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-01-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078780-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-01-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078780-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2010-01-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078780-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2010-01-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078780-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-01-21 2680178bc6a6…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cetirizine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETIRIZINE HYDROCHLORIDE 10 mg/1
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 65162-046-03 Cetirizine Hydrochloride 1 in 1 CARTON TABLET 1 7 65162-046-03 Cetirizine Hydrochloride 30 in 1 BOTTLE TABLET 30 7 65162-046-50 Cetirizine Hydrochloride 500 in 1 BOTTLE TABLET 500 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-046 CETIRIZINE HYDROCHLORIDE (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS LLC] 7 Current NDC, Legacy NDC, 3 package rows 20240808_273172b2-9aaf-46fb-a1ce-2961650eacd3.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65162-046-03 65162004603 1 BOTTLE in 1 CARTON (65162-046-03) / 30 TABLET in 1 BOTTLE 1 bottle 2010-01-21 No No Current 65162-046-50 65162004650 500 TABLET in 1 BOTTLE (65162-046-50) 500 tablet 2010-01-21 No No Current