Home NDC 63187-436-04 Cetirizine Hydrochloride
Product NDC 63187-436
Requested package NDC 63187-436-04
11-digit product format 631870436
Labeler code 63187
Product ID 63187-436_94b97b2e-11b6-42ad-96f5-3d4030347dd7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Proficient Rx LP
Application ANDA078488
Marketing category ANDA
Marketing start 2013-12-03
Marketing end 0000-00-00
Substance CETIRIZINE HYDROCHLORIDE
Active strength 1 mg/mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 2 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 63187-436 63187-436-04 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63187-436 63187-436-04 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078488-001 CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078488-001 AA
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 2 · 43 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 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078488-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-10-06 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-436 CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP] 3 Legacy NDC 20200219_26d8bc1c-59bc-425a-bdb0-5f97e6dcdbe0.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 · 1 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 63187-436-04 63187043604 120 mL in 1 BOTTLE, GLASS (63187-436-04) 120 ml 2019-01-01 0000-00-00 No No Current