Home NDC 71610-862 cetirizine hydrochloride
Product NDC 71610-862
11-digit product format 716100862
Labeler code 71610
Product ID 71610-862_25db6e82-df00-8206-e063-6294a90a5594
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA078336
Marketing category ANDA
Marketing start 2007-12-27
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 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2007-12-27 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2007-12-27 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2007-12-27 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2007-12-27
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 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 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 71610-862-30 cetirizine hydrochloride 30 in 1 BOTTLE TABLET 30 1 71610-862-60 cetirizine hydrochloride 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-862 CETIRIZINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] 1 Current NDC, 2 package rows 20241105_25db4ca0-0c25-f3b6-e063-6394a90a8851.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 3 of 3 · 43 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 71610-862-30 71610086230 30 TABLET in 1 BOTTLE (71610-862-30) 30 tablet 2024-10-28 No No Current 71610-862-60 71610086260 90 TABLET in 1 BOTTLE (71610-862-60) 90 tablet 2024-10-28 No No Current