Home NDC 14445-152 CETIRIZINE HYDROCHLORIDE
Product NDC 14445-152
11-digit product format 144450152
Labeler code 14445
Product ID 14445-152_c1a05a6d-3db7-446f-927b-787a062ad1ae
Type HUMAN OTC DRUG
Nonproprietary name CETIRIZINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Indoco Remedies Limited
Application ANDA218895
Marketing category ANDA
Marketing start 2024-10-04
Substance CETIRIZINE HYDROCHLORIDE
Active strength 10 mg/1
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 A218895-001 CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2024-10-03
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.
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 A218895-001 CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2024-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218895-001 CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2024-10-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218895-001 CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2024-10-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218895-001 CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2024-10-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218895-001 CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2024-10-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218895-001 CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2024-10-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218895-001 CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2024-10-03 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218895-001 CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2024-10-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218895-001 CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2024-10-03 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218895-001 CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2024-10-03 a50c72e98297…
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 10 mg/1
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 1014678 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 14445-152-01 CETIRIZINE HYDROCHLORIDE 100 in 1 BOTTLE TABLET, FILM COATED 100 6 14445-152-01 CETIRIZINE HYDROCHLORIDE 1 in 1 CARTON TABLET, FILM COATED 1 6 14445-152-03 CETIRIZINE HYDROCHLORIDE 300 in 1 BOTTLE TABLET, FILM COATED 300 6 14445-152-03 CETIRIZINE HYDROCHLORIDE 1 in 1 CARTON TABLET, FILM COATED 1 6 14445-152-05 CETIRIZINE HYDROCHLORIDE 500 in 1 BOTTLE TABLET, FILM COATED 500 6 14445-152-05 CETIRIZINE HYDROCHLORIDE 1 in 1 CARTON TABLET, FILM COATED 1 6 14445-152-30 CETIRIZINE HYDROCHLORIDE 30 in 1 BOTTLE TABLET, FILM COATED 30 6 14445-152-30 CETIRIZINE HYDROCHLORIDE 1 in 1 CARTON TABLET, FILM COATED 1 6 14445-152-90 CETIRIZINE HYDROCHLORIDE 90 in 1 BOTTLE TABLET, FILM COATED 90 6 14445-152-90 CETIRIZINE HYDROCHLORIDE 1 in 1 CARTON TABLET, FILM COATED 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14445-152 CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [INDOCO REMEDIES LIMITED ] 6 Current NDC, 10 package rows 20241010_2942e093-5077-44d3-b080-8d945d03c55f.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 Sample Exclude flag Status 14445-152-01 14445015201 1 BOTTLE in 1 CARTON (14445-152-01) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-10-04 No No Current 14445-152-03 14445015203 1 BOTTLE in 1 CARTON (14445-152-03) / 300 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-10-04 No No Current 14445-152-05 14445015205 1 BOTTLE in 1 CARTON (14445-152-05) / 500 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-10-04 No No Current 14445-152-30 14445015230 1 BOTTLE in 1 CARTON (14445-152-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-10-04 No No Current 14445-152-90 14445015290 1 BOTTLE in 1 CARTON (14445-152-90) / 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-10-04 No No Current