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 43598-810
Product ID 43598-810_ea46c444-7f75-7cd9-4030-3a59be54ccdc
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210375
Listing Expiration 2027-12-31
Marketing Start 2018-12-26

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 43598810
Hyphenated Format 43598-810

Supplemental Identifiers

RxCUI
855172
UNII
SOD6A38AGA

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
  • 2 BOTTLE in 1 CARTON (43598-810-76) / 80 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43598-810-80) / 80 TABLET, COATED in 1 BOTTLE
source: ndc

Packages (2)

43598-810-76 2 BOTTLE in 1 CARTON (43598-810-76) / 80 TABLET, COATED in 1 BOTTLE 43598-810-80 1 BOTTLE in 1 CARTON (43598-810-80) / 80 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": "ea46c444-7f75-7cd9-4030-3a59be54ccdc", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["fb0a3619-9d5b-5c58-82f3-31f031672f33"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (43598-810-76)  / 80 TABLET, COATED in 1 BOTTLE", "package_ndc": "43598-810-76", "marketing_start_date": "20181226"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-810-80)  / 80 TABLET, COATED in 1 BOTTLE", "package_ndc": "43598-810-80", "marketing_start_date": "20181226"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "43598-810_ea46c444-7f75-7cd9-4030-3a59be54ccdc", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "43598-810", "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": "20181226", "listing_expiration_date": "20271231"}