Home NDC 63629-4914 Cetirizine Hydrochloride
Product NDC 63629-4914
11-digit product format 636294914
Labeler code 63629
Product ID 63629-4914_3db925ae-d07d-4da4-9dab-155db44d75a0
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA077829
Marketing category ANDA
Marketing start 2009-10-01
Substance CETIRIZINE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 63629-4914-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 63629-4914-1 1332a3947898…d4bfe170f9cd…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 63629-4914-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63629-4914-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63629-4914-1 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 63629-4914-1 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 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.
Additional Listing Data#
Finished product Yes
Brand name base Cetirizine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETIRIZINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 64O047KTOA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1014676 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 63629-4914-1 Cetirizine Hydrochloride 30 in 1 BOTTLE TABLET 30 1003
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-4914 CETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 1003 Current NDC, Legacy NDC, 1 package rows 20240524_ddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be7.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 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
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 63629-4914-1 63629491401 30 TABLET in 1 BOTTLE (63629-4914-1) 30 tablet 2013-02-19 0000-00-00 No No Current