cetirizine hydrochloride

Generic: cetirizine hydrochloride tablets

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride tablets
Labeler dr. reddy's laboratories inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-811
Product ID 43598-811_adfee3f6-660a-305c-2cf4-bd509acfad36
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078343
Listing Expiration 2026-12-31
Marketing Start 2018-12-17

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598811
Hyphenated Format 43598-811

Supplemental Identifiers

RxCUI
1014678
UNII
64O047KTOA

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cetirizine hydrochloride (source: ndc)
Generic Name cetirizine hydrochloride tablets (source: ndc)
Application Number ANDA078343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (43598-811-05) / 500 TABLET, FILM COATED in 1 BOTTLE
  • 100 TABLET, FILM COATED in 1 BOTTLE (43598-811-12)
  • 300 TABLET, FILM COATED in 1 BOTTLE (43598-811-13)
  • 500 TABLET, FILM COATED in 1 BOTTLE (43598-811-15)
  • 1 BOTTLE in 1 CARTON (43598-811-30) / 300 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43598-811-90) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (6)

43598-811-05 1 BOTTLE in 1 CARTON (43598-811-05) / 500 TABLET, FILM COATED in 1 BOTTLE 43598-811-12 100 TABLET, FILM COATED in 1 BOTTLE (43598-811-12) 43598-811-13 300 TABLET, FILM COATED in 1 BOTTLE (43598-811-13) 43598-811-15 500 TABLET, FILM COATED in 1 BOTTLE (43598-811-15) 43598-811-30 1 BOTTLE in 1 CARTON (43598-811-30) / 300 TABLET, FILM COATED in 1 BOTTLE 43598-811-90 1 BOTTLE in 1 CARTON (43598-811-90) / 90 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "adfee3f6-660a-305c-2cf4-bd509acfad36", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["e4eca4df-9ad8-b7c4-b512-bfaed5673789"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-811-05)  / 500 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "43598-811-05", "marketing_start_date": "20181217"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (43598-811-12)", "package_ndc": "43598-811-12", "marketing_start_date": "20190903"}, {"sample": false, "description": "300 TABLET, FILM COATED in 1 BOTTLE (43598-811-13)", "package_ndc": "43598-811-13", "marketing_start_date": "20190903"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (43598-811-15)", "package_ndc": "43598-811-15", "marketing_start_date": "20190903"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-811-30)  / 300 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "43598-811-30", "marketing_start_date": "20181217"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-811-90)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "43598-811-90", "marketing_start_date": "20181217"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "43598-811_adfee3f6-660a-305c-2cf4-bd509acfad36", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "43598-811", "generic_name": "Cetirizine Hydrochloride Tablets", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078343", "marketing_category": "ANDA", "marketing_start_date": "20181217", "listing_expiration_date": "20261231"}