Home NDC 69452-465 CETIRIZINE HYDROCHLORIDE
Product NDC 69452-465
11-digit product format 694520465
Labeler code 69452
Product ID 69452-465_45745bf3-a132-b51a-e063-6394a90a712e
Type HUMAN OTC DRUG
Nonproprietary name CETIRIZINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bionpharma Inc.
Application ANDA078862
Marketing category ANDA
Marketing start 2024-10-20
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2009-02-19 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2009-02-19 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2009-02-19 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2009-02-19
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 · 172 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 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 5bbf6a4d5a75…
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 10 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 1014678 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69452-465-81 CETIRIZINE HYDROCHLORIDE 400 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 400 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-465 CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [BIONPHARMA INC.] 1 Current NDC, 1 package rows 20241021_831d4141-b3be-4d98-a372-9c4d57ad296c.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69452-465-81 69452046581 400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-465-81) 2024-10-20 No No Current