Home NDC 0781-5283-64 Cetirizine Hydrochloride
Product NDC 0781-5283
Requested package NDC 0781-5283-64
11-digit product format 007815283
Labeler code 0781
Product ID 0781-5283_973d0d70-f69f-44b6-98f0-f436e63bd15a
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Sandoz Inc
Application ANDA078692
Marketing category ANDA
Marketing start 2008-02-14
Substance CETIRIZINE HYDROCHLORIDE
Active strength 5 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2008-02-14 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14
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 3 · 86 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 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078692-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2008-02-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078692-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL RS 2008-02-14 74a2ff9319b5…
Additional Listing Data#
Finished product Yes
Brand name base Cetirizine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETIRIZINE HYDROCHLORIDE 5 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 1014643 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 0781-5283-06 Cetirizine Hydrochloride 1 in 1 BLISTER PACK TABLET, CHEWABLE 1 7 0781-5283-64 Cetirizine Hydrochloride 30 in 1 CARTON TABLET, CHEWABLE 30 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CETIRIZINE HYDROCHLORIDE ACTIVE INGREDIENT 64O047KTOA CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2 CETIRIZINE ACTIVE MOIETY YO7261ME24 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2 .ALPHA.-TOCOPHEROL ACETATE, DL- INACTIVE INGREDIENT WR1WPI7EW8 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2 BETADEX INACTIVE INGREDIENT JV039JZZ3A CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-5283 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] 7 Current NDC, Legacy NDC, 2 package rows 20250201_817d07cf-5e31-421f-9e95-943bae01f5b0.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 · 2 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 0781-5283-64 00781528364 30 BLISTER PACK in 1 CARTON (0781-5283-64) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5283-06) 30 blister pack 2008-02-14 0000-00-00 No No Current