Home NDC 51672-4070-8 Cetirizine Hydrochloride
Product NDC 51672-4070
Requested package NDC 51672-4070-8
11-digit product format 516724070
Labeler code 51672
Product ID 51672-4070_3b528d29-2957-8382-e063-6294a90aa8a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA076601
Marketing category ANDA
Marketing start 2014-05-01
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 A076601-001 CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076601-001 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 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2008-06-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076601-001 CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP / ORAL AA 2008-06-20 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 51672-4070-8 Cetirizine Hydrochloride 120 mL in 1 BOTTLE SOLUTION 120 14 51672-4070-8 Cetirizine Hydrochloride 1 in 1 CARTON SOLUTION 1 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Cetirizine Hydrochloride ACTIVE INGREDIENT 64O047KTOA CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 Cetirizine ACTIVE MOIETY YO7261ME24 CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 acetic acid INACTIVE INGREDIENT Q40Q9N063P CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 sodium acetate anhydrous INACTIVE INGREDIENT NVG71ZZ7P0 CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 sucrose INACTIVE INGREDIENT C151H8M554 CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4070 CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 12 Current NDC, Legacy NDC, 2 package rows 20250116_6d81446e-f713-4ca4-af38-3d31cf618873.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 · 4 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 51672-4070-8 51672407008 1 BOTTLE in 1 CARTON (51672-4070-8) / 120 mL in 1 BOTTLE 1 bottle 2014-05-01 0000-00-00 No No Current