Home NDC 69206-990 Cetirizine Hydrochloride
Product NDC 69206-990
11-digit product format 692060990
Labeler code 69206
Product ID 69206-990_3e808491-ec96-4f20-bb5e-3a9e5c72550e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Aventura Pharmaceuticals, LLC
Application ANDA078876
Marketing category ANDA
Marketing start 2023-02-01
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078876-001 CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078876-001 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 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2012-05-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078876-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2012-05-11 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 1 mg/mL
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 1014673 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 69206-990-01 Cetirizine Hydrochloride 120 mL in 1 BOTTLE SOLUTION 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69206-990 CETIRIZINE HYDROCHLORIDE SOLUTION [AVENTURA PHARMACEUTICALS, LLC] 2 Current NDC, 1 package rows 20241011_aeb73ab9-3b05-4062-a7fd-352cf2094a56.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 · 3 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 69206-990-01 69206099001 120 mL in 1 BOTTLE (69206-990-01) 120 ml 2023-02-01 No No Current