Home NDC 49483-682-01 Cetirizine Hydrochloride
Product NDC 49483-682
Requested package NDC 49483-682-01
11-digit product format 494830682
Labeler code 49483
Product ID 49483-682_dfbdaf6a-c5e8-c5f9-e053-2995a90ae2c6
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler TIME CAP LABORATORIES, INC.
Application ANDA078933
Marketing category ANDA
Marketing start 2022-05-30
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 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 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2010-06-15 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-06-15 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2010-06-15 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-06-15
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 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49483-682-01 Cetirizine Hydrochloride 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-682 CETIRIZINE HYDROCHLORIDE TABLET [TIME CAP LABORATORIES, INC.] 1 Current NDC, Legacy NDC, 1 package rows 20220530_dfbddafb-9455-5805-e053-2a95a90ad0d9.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 · 8 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape) CETIRIZINE HYDROCHLORIDE MARKSANS PHARMA LIMITED 652b0c65-a3f2-4454-9cf2-51a3389282cc 2026-07-10 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 Cetirizine Hydrochloride Tablets,10 mg CETIRIZINE HYDROCHLORIDE Northwind Health Company, LLC f756d3b1-d2e4-3705-e053-6294a90aa380 2026-01-01 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 ALLERGY CETIRIZINE HYDROCHLORIDE Kroger Company bc020340-ef39-e49a-e053-2a95a90af810 2025-09-11 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 Allergy Relief CETIRIZINE HYDROCHLORIDE BETTER LIVING BRANDS, LLC eb60ae7d-87db-7413-e053-2a95a90afd76 2025-06-28 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 Cetirizine Hydrochloride Tablets,10 mg CETIRIZINE HYDROCHLORIDE TIME CAP LABORATORIES, INC. d78223ba-80d5-47f8-e053-2a95a90aebdb 2024-03-06 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 All Day Allergy Relief CETIRIZINE HYDROCHLORIDE DOLGENCORP, INC. 0643ea78-9709-8526-e063-6394a90a227b 2023-12-15 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 Allergy Relief CETIRIZINE HYDROCHLORIDE WALGREENS f3c66f47-016a-799a-e053-2995a90ad424 2023-10-21 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE TIME CAP LABORATORIES, INC. dfbddafb-9455-5805-e053-2a95a90ad0d9 2022-05-24 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 ndc (package): 49483-682-01 ndc (product): 49483-682 ndc11 (package): 49483068201
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 49483-682-01 49483068201 100 TABLET in 1 BOTTLE (49483-682-01) 100 tablet 2022-05-30 0000-00-00 No No Current