levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

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

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler dr. reddy's laboratories inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-735
Product ID 43598-735_0b6d0486-2682-21fe-de0a-72d69a4b32c9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210375
Listing Expiration 2026-12-31
Marketing Start 2018-03-12

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 43598735
Hyphenated Format 43598-735

Supplemental Identifiers

RxCUI
855172
UNII
SOD6A38AGA

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 levocetirizine dihydrochloride (source: ndc)
Generic Name levocetirizine dihydrochloride (source: ndc)
Application Number ANDA210375 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (43598-735-04) / 120 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43598-735-22) / 55 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43598-735-30) / 30 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43598-735-35) / 35 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43598-735-58) / 10 TABLET, COATED in 1 BOTTLE
  • 2 BLISTER PACK in 1 CARTON (43598-735-79) / 5 TABLET, COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (43598-735-80) / 80 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43598-735-90) / 90 TABLET, COATED in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (43598-735-95) / 200 TABLET, COATED in 1 BOTTLE
source: ndc

Packages (9)

43598-735-04 1 BOTTLE in 1 CARTON (43598-735-04) / 120 TABLET, COATED in 1 BOTTLE 43598-735-22 1 BOTTLE in 1 CARTON (43598-735-22) / 55 TABLET, COATED in 1 BOTTLE 43598-735-30 1 BOTTLE in 1 CARTON (43598-735-30) / 30 TABLET, COATED in 1 BOTTLE 43598-735-35 1 BOTTLE in 1 CARTON (43598-735-35) / 35 TABLET, COATED in 1 BOTTLE 43598-735-58 1 BOTTLE in 1 CARTON (43598-735-58) / 10 TABLET, COATED in 1 BOTTLE 43598-735-79 2 BLISTER PACK in 1 CARTON (43598-735-79) / 5 TABLET, COATED in 1 BLISTER PACK 43598-735-80 1 BOTTLE in 1 CARTON (43598-735-80) / 80 TABLET, COATED in 1 BOTTLE 43598-735-90 1 BOTTLE in 1 CARTON (43598-735-90) / 90 TABLET, COATED in 1 BOTTLE 43598-735-95 2 BOTTLE in 1 CARTON (43598-735-95) / 200 TABLET, COATED in 1 BOTTLE

Ingredients (1)

levocetirizine dihydrochloride (5 mg/1)

Linked Drug Pages (1)

levocetirizine dihydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0b6d0486-2682-21fe-de0a-72d69a4b32c9", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["1f722b84-08de-7e6a-41ac-2c9d9bb9fb43"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-735-04)  / 120 TABLET, COATED in 1 BOTTLE", "package_ndc": "43598-735-04", "marketing_start_date": "20200215"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-735-22)  / 55 TABLET, COATED in 1 BOTTLE", "package_ndc": "43598-735-22", "marketing_start_date": "20180312"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-735-30)  / 30 TABLET, COATED in 1 BOTTLE", "package_ndc": "43598-735-30", "marketing_start_date": "20180820"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-735-35)  / 35 TABLET, COATED in 1 BOTTLE", "package_ndc": "43598-735-35", "marketing_start_date": "20180312"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-735-58)  / 10 TABLET, COATED in 1 BOTTLE", "package_ndc": "43598-735-58", "marketing_start_date": "20250730"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (43598-735-79)  / 5 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "43598-735-79", "marketing_start_date": "20180417"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-735-80)  / 80 TABLET, COATED in 1 BOTTLE", "package_ndc": "43598-735-80", "marketing_start_date": "20180312"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-735-90)  / 90 TABLET, COATED in 1 BOTTLE", "package_ndc": "43598-735-90", "marketing_start_date": "20180820"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (43598-735-95)  / 200 TABLET, COATED in 1 BOTTLE", "package_ndc": "43598-735-95", "marketing_start_date": "20231027"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "43598-735_0b6d0486-2682-21fe-de0a-72d69a4b32c9", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "43598-735", "generic_name": "levocetirizine dihydrochloride", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "levocetirizine dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA210375", "marketing_category": "ANDA", "marketing_start_date": "20180312", "listing_expiration_date": "20261231"}