Home NDC 63868-132 Quality Choice Cetirizine Hydrochloride
Product NDC 63868-132
11-digit product format 638680132
Labeler code 63868
Product ID 63868-132_2f9f8dc0-8034-445c-b7b0-bf680a6be979
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Chain Drug Marketing Association Inc.
Application ANDA077498
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 1 .
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 A077498-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2007-12-27 A077498-002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2007-12-27 A077498-003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2007-12-27 A077498-004 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.
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 2026-08-01 22:54:32 2026-06 A077498-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A077498-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A077498-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A077498-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 14 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Sportpharm LLC 357523b6-618b-4bff-a80d-c62e72a0804e 2026-05-08 Warnings Exact identifier application applno (ANDA): 077498 application number: ANDA077498 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. a7da81e1-8865-45c9-83c7-32fb8032ca2e 2026-03-19 Warnings Exact identifier application applno (ANDA): 077498 application number: ANDA077498 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Marlex Pharmaceuticals, Inc eb917099-fecf-6b55-e053-2995a90aaafa 2025-09-23 Warnings Exact identifier application applno (ANDA): 077498 application number: ANDA077498 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. d0d8b376-9001-8776-e053-2a95a90ae651 2024-08-12 Warnings Exact identifier application applno (ANDA): 077498 application number: ANDA077498 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 15eaa0d1-d18d-72b1-e063-6394a90a8a94 2024-04-12 Warnings Exact identifier application applno (ANDA): 077498 application number: ANDA077498 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Proficient Rx LP d14feb90-3ca2-4d5b-825c-25fc2252ca38 2022-06-01 Warnings Exact identifier application applno (ANDA): 077498 application number: ANDA077498 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Ohm Laboratories Inc. 161c4122-2c89-46e6-a6ae-db088087330d 2021-05-21 Warnings Exact identifier application applno (ANDA): 077498 application number: ANDA077498 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Publix Super Markets Inc a0a063a1-e067-480e-afab-7f01165025f4 2019-08-19 Warnings Exact identifier application applno (ANDA): 077498 application number: ANDA077498 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Chain Drug Consortium, LLC 9d7d2342-a594-4851-810b-b7bce1bd07dc 2018-08-24 Warnings Exact identifier application applno (ANDA): 077498 application number: ANDA077498 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Valu Merchandisers Company 4a8d2887-8ac3-4d54-9e67-4a271d416426 2018-08-23 Warnings Exact identifier application applno (ANDA): 077498 application number: ANDA077498 Quality Choice Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Chain Drug Marketing Association Inc. 2e8cc4e3-8386-42de-801f-fef37f612849 2018-08-22 Warnings Exact identifier application applno (ANDA): 077498 application number: ANDA077498 ndc (product): 63868-132 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Marc Glassman, Inc. f30900e6-425f-43e0-81b6-1fa3bd321f0b 2018-06-20 Warnings Exact identifier application applno (ANDA): 077498 application number: ANDA077498 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE LIDL US, LLC a210d6b7-0829-4120-bb6d-fee0c2e57b26 2018-01-09 Warnings Exact identifier application applno (ANDA): 077498 application number: ANDA077498 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE FAMILY DOLLAR SERVICES, INC b326dacc-6123-47a7-9fde-6909db1d780b 2018-01-08 Warnings Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Additional Listing Data#
Finished product Yes
Brand name base Quality Choice 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 63868-132-14 Quality Choice Cetirizine Hydrochloride 14 in 1 BLISTER PACK TABLET 14 2 63868-132-30 Quality Choice Cetirizine Hydrochloride 30 in 1 BOTTLE TABLET 30 2 63868-132-90 Quality Choice Cetirizine Hydrochloride 90 in 1 BOTTLE TABLET 90 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-132 QUALITY CHOICE CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.] 2 Current NDC, Legacy NDC, 3 package rows 20180824_2e8cc4e3-8386-42de-801f-fef37f612849.zip
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 63868-132-14 63868013214 14 TABLET in 1 BLISTER PACK (63868-132-14) 14 tablet 2007-12-27 0000-00-00 No No Current 63868-132-30 63868013230 30 TABLET in 1 BOTTLE (63868-132-30) 30 tablet 2007-12-27 0000-00-00 No No Current 63868-132-90 63868013290 90 TABLET in 1 BOTTLE (63868-132-90) 90 tablet 2007-12-27 0000-00-00 No No Current