Home NDC 0781-1684 Cetirizine Hydrochloride
Product NDC 0781-1684
11-digit product format 007811684
Labeler code 0781
Product ID 0781-1684_2ca4b053-0031-4a34-a1b1-8eaadb0879c6
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Sandoz Inc
Application ANDA077946
Marketing category ANDA
Marketing start 2007-12-27
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077946-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2007-12-27 A077946-002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2007-12-27
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 2026-08-01 22:54:32 2026-06 A077946-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A077946-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 0781-1684-01 Cetirizine Hydrochloride 100 in 1 BOTTLE TABLET 100 3 0781-1684-64 Cetirizine Hydrochloride 30 in 1 BOX, UNIT-DOSE TABLET 30 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CETIRIZINE HYDROCHLORIDE ACTIVE INGREDIENT 64O047KTOA CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 CETIRIZINE ACTIVE MOIETY YO7261ME24 CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 POVIDONES INACTIVE INGREDIENT FZ989GH94E CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 CETIRIZINE HYDROCHLORIDE ACTIVE INGREDIENT 64O047KTOA CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 3 CETIRIZINE HYDROCHLORIDE ACTIVE INGREDIENT 64O047KTOA CETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 3 CETIRIZINE ACTIVE MOIETY YO7261ME24 CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 3 CETIRIZINE ACTIVE MOIETY YO7261ME24 CETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 3 POLYETHYLENE GLYCOLs INACTIVE INGREDIENT 3WJQ0SDW1A CETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E CETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CETIRIZINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 3 CETIRIZINE HYDROCHLORIDE ACTIVE INGREDIENT 64O047KTOA CETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC] 2 CETIRIZINE HYDROCHLORIDE ACTIVE INGREDIENT 64O047KTOA CETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CETIRIZINE ACTIVE MOIETY YO7261ME24 CETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CETIRIZINE ACTIVE MOIETY YO7261ME24 CETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E CETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E CETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CETIRIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-1684 CETIRIZINE HYDROCHLORIDE TABLET [SANDOZ INC] 3 Current NDC, Legacy NDC, 2 package rows 20191126_760dd0e4-280a-4d95-8938-cecaa7ec75f2.zip
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 0781-1684-01 00781168401 100 TABLET in 1 BOTTLE (0781-1684-01) 100 tablet 2007-12-27 0000-00-00 No No Current 0781-1684-64 00781168464 30 TABLET in 1 BOX, UNIT-DOSE (0781-1684-64) 30 tablet 2007-12-27 0000-00-00 No No Current