Home NDC 65162-684 Cetirizine Hydrochloride
Product NDC 65162-684
11-digit product format 651620684
Labeler code 65162
Product ID 65162-684_9cc0ee28-2f21-4c0a-90fe-b22b3fe321c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cetirizine
Dosage form SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA090766
Marketing category ANDA
Marketing start 2009-10-07
Substance CETIRIZINE HYDROCHLORIDE
Active strength 5 mg/5mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090766-001 CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090766-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-10-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090766-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-10-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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/5mL
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 65162-684-86 Cetirizine Hydrochloride 118 mL in 1 BOTTLE SOLUTION 118 18 65162-684-90 Cetirizine Hydrochloride 473 mL in 1 BOTTLE SOLUTION 473 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-684 CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS LLC] 17 Current NDC, Legacy NDC, 2 package rows 20241025_365cbabe-535b-4c34-852b-6cd63782e3e5.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.
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 65162-684-86 65162068486 118 mL in 1 BOTTLE (65162-684-86) 118 ml 2009-10-07 0000-00-00 No No Current 65162-684-90 65162068490 473 mL in 1 BOTTLE (65162-684-90) 473 ml 2009-10-07 0000-00-00 No No Current