Home NDC 70985-002-05 Cetirizine Hydrochloride
Product NDC 70985-002
Requested package NDC 70985-002-05
11-digit product format 709850002
Labeler code 70985
Product ID 70985-002_ecfc99f8-fcbd-e91a-e053-2995a90a9e05
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Drug Ocean LLC
Application ANDA077829
Marketing category ANDA
Marketing start 2016-11-08
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70985-002 70985-002-05 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 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 · 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 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…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 5bbf6a4d5a75…
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70985-002 CETIRIZINE HYDROCHLORIDE TABLET [DRUG OCEAN LLC] 5 Legacy NDC 20231224_ef78fb17-6905-4961-ab85-7f312b6555d0.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 · 26 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70985-002-05 70985000205 300 TABLET in 1 BOTTLE (70985-002-05) 300 tablet 2021-08-05 0000-00-00 No No Current