Home NDC 61037-479 CETIRIZINE HYDROCHLORIDE
Product NDC 61037-479
11-digit product format 610370479
Labeler code 61037
Product ID 61037-479_3b5908fd-b2c0-ba45-e063-6294a90a6fb0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CETIRIZINE HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler BAJAJ MEDICAL, LLC
Application ANDA090191
Marketing category ANDA
Marketing start 2023-09-12
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 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 A090191-001 CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090191-001 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 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2009-11-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090191-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2009-11-12 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 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 61037-479-02 CETIRIZINE HYDROCHLORIDE 120 mL in 1 BOTTLE, PLASTIC SOLUTION 120 9 61037-479-03 CETIRIZINE HYDROCHLORIDE 480 mL in 1 BOTTLE, PLASTIC SOLUTION 480 9 61037-479-06 CETIRIZINE HYDROCHLORIDE 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 9 61037-479-12 CETIRIZINE HYDROCHLORIDE 5 mL in 1 BOX, UNIT-DOSE SOLUTION 5 9 61037-479-04 CETIRIZINE HYDROCHLORIDE 240 mL in 1 BOTTLE, PLASTIC SOLUTION 240 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61037-479 CETIRIZINE HYDROCHLORIDE SOLUTION [BAJAJ MEDICAL, LLC] 6 Current NDC, 4 package rows 20250519_05324e41-ee3f-0e4b-e063-6294a90a102c.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 61037-479-02 61037047902 120 mL in 1 BOTTLE, PLASTIC (61037-479-02) 120 ml 2023-09-12 No No Current 61037-479-03 61037047903 480 mL in 1 BOTTLE, PLASTIC (61037-479-03) 480 ml 2024-07-16 No No Current 61037-479-04 61037047904 240 mL in 1 BOTTLE, PLASTIC (61037-479-04) 240 ml 2025-06-06 No No Current 61037-479-06 61037047906 5 mL in 1 CUP, UNIT-DOSE (61037-479-06) 5 ml 2025-06-06 No No Current 61037-479-12 61037047912 5 mL in 1 BOX, UNIT-DOSE (61037-479-12) 5 ml 2025-06-06 No No Current