Home NDC 35356-864 Cetirizine Hydrochloride
Product NDC 35356-864
11-digit product format 353560864
Labeler code 35356
Product ID 35356-864_d31caf84-09ad-486f-a2de-fdd080287d15
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
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 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 · 60 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 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 35356-864-90 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 35356-864-60 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 35356-864-30 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 35356-864-90 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 35356-864-60 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 35356-864-30 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 35356-864-90 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 35356-864-60 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 35356-864-30 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 35356-864-90 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 35356-864-60 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 35356-864-30 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 35356-864-90 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 35356-864-60 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 35356-864-30 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 35356-864-90 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 35356-864-60 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 35356-864-30 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 35356-864-90 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 35356-864-60 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 35356-864-30 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 35356-864-90 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 35356-864-60 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 35356-864-30 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 35356-864-90 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 35356-864-30 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 35356-864-60 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 35356-864-90 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 35356-864-30 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 35356-864-60 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 35356-864-90 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 35356-864-30 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 35356-864-60 D Discontinued by firm 367a005e9d99…383a685ebd0f…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 35356-864-90 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 35356-864-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 35356-864-60 D Discontinued by firm 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 35356-864-30 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 35356-864-30 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 35356-864-30 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 35356-864-30 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 35356-864-30 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 35356-864-30 I Inactivated by FDA bd6a592717d7…303034d00443…
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 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2009-08-26 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL RS 2009-08-26 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2009-08-26 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2009-08-26
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 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 2680178bc6a6…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 35356-864-30 2025-01-14 Cetirizine Hydrochloride Tablets, 10 mg, Allergy 35356-864-60 2025-01-14 Cetirizine Hydrochloride Tablets, 10 mg, Allergy 35356-864-90 2025-01-14 Cetirizine Hydrochloride Tablets, 10 mg, Allergy 35356-864-30 2022-01-28 Cetirizine Hydrochloride Tablets, 10 mg, Allergy 35356-864-60 2022-01-28 Cetirizine Hydrochloride Tablets, 10 mg, Allergy 35356-864-90 2022-01-28 Cetirizine Hydrochloride Tablets, 10 mg, Allergy
DailyMed Socrata Ingredients# 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 2 · 25 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GOOD REMEDIES All Day Allergy Relief CETIRIZINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 44410d76-5940-4611-be45-579e2db8a65d 2026-08-24 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE NuCare Pharmaceuticals, Inc. 4913192a-7364-3f19-e054-00144ff8d46c 2026-08-20 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE St. Mary's Medical Park Pharmacy f2f42f36-6b09-4140-e053-2a95a90af813 2026-06-29 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Allergy Relief CETIRIZINE HCL Pioneer Life Sciences, LLC 5249b83c-30d4-4b5b-aeb1-f52418ba079f 2026-04-06 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Indoor and Outdoor Allergy Relief CETIRIZINE HCL Famora Inc. 2a94d25c-aacf-4f5c-b406-815f0e1d0611 2026-03-18 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Sportpharm LLC dd50d2e9-3de7-4c44-96ed-39ef04dae702 2026-02-06 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Allergy Relief CETIRIZINE HYDROCHLORIDE Strategic Sourcing Services LLC 54509525-ad99-4165-a571-47ece058e292 2026-01-29 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Allergy Relief CETIRIZINE HYDROCHLORIDE Prodose, Inc e0e5f482-0282-410c-8c40-0a33ca4ea23a 2026-01-26 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Allergy Relief CETIRIZINE HCL Pioneer Life Sciences, LLC 205b42e0-9d02-4755-9ee6-5883147abeb3 2025-12-23 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Allergy Relief CETIRIZINE HCL Pioneer Life Sciences, LLC b275feae-56a1-4a60-a564-8d7b18c06aa2 2025-12-23 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Allergy Relief CETIRIZINE HCL NUVICARE LLC c728edf3-e6b5-4860-b966-39cf3ee4ff77 2025-12-19 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 RIGHT REMEDIES ALL-DAY Allergy Relief CETIRIZINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 8227edbe-88d5-4d79-9175-891dd9566357 2025-11-20 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Rising Pharma Holdings, Inc. 5481ccb3-b311-4b25-b923-4fe8522ea92b 2025-11-05 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 ValuMeds All Day Allergy Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Cabinet Health P.B.C. 3071238a-6b35-4da8-8305-eced56c513ce 2025-10-23 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 CVS Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CVS Pharmacy 3d711302-dc4e-0a69-e063-6394a90ade10 2025-09-18 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Cabinet Allergy Relief Refill Cetirizine HCI CETIRIZINE HYDROCHLORIDE Cabinet Health P.B.C. 0eaf9d27-e221-4cdd-97bc-478c775e3d67 2025-07-03 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Allergy Relief CETIRIZINE HCL NUVICARE LLC 09dfdce2-7184-4247-983c-a5667e4a9da1 2025-06-09 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 ALLERGY RELIEF CETIRIZINE HCL Pioneer Life Sciences, LLC 110adf3c-84ce-48a1-8a22-89ee3eec22d9 2025-06-01 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Cabinet All Day Allergy Relief CETIRIZINE HYDROCHLORIDE Cabinet Health P.B.C. 889316bc-5f98-426a-9750-2fdb0c427408 2025-04-07 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Umasuto, LLC 9af4ab23-d6d3-43f9-a026-76fd9771963f 2025-03-06 Warnings Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 35356-864-30 35356086430 30 TABLET in 1 BOTTLE (35356-864-30) 30 tablet 2009-10-01 0000-00-00 No No Current