levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: heb
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler heb
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
HEB

Identifiers & Regulatory

Product NDC 37808-126
Product ID 37808-126_a08f35dd-f3d5-5689-c975-0ed213c90c7d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210375
Listing Expiration 2027-12-31
Marketing Start 2019-06-15

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 37808126
Hyphenated Format 37808-126

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 BLISTER PACK in 1 BLISTER PACK (37808-126-10) / 5 TABLET, COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 BOTTLE (37808-126-35) / 35 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (37808-126-80) / 80 TABLET, COATED in 1 BOTTLE
source: ndc

Packages (3)

37808-126-10 2 BLISTER PACK in 1 BLISTER PACK (37808-126-10) / 5 TABLET, COATED in 1 BLISTER PACK 37808-126-35 1 BOTTLE in 1 BOTTLE (37808-126-35) / 35 TABLET, COATED in 1 BOTTLE 37808-126-80 1 BOTTLE in 1 CARTON (37808-126-80) / 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": "a08f35dd-f3d5-5689-c975-0ed213c90c7d", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["b13ab6fc-4fec-c870-2c5f-b5e31dec722a"], "manufacturer_name": ["HEB"]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 BLISTER PACK (37808-126-10)  / 5 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "37808-126-10", "marketing_start_date": "20190615"}, {"sample": false, "description": "1 BOTTLE in 1 BOTTLE (37808-126-35)  / 35 TABLET, COATED in 1 BOTTLE", "package_ndc": "37808-126-35", "marketing_start_date": "20190615"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (37808-126-80)  / 80 TABLET, COATED in 1 BOTTLE", "package_ndc": "37808-126-80", "marketing_start_date": "20221001"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "37808-126_a08f35dd-f3d5-5689-c975-0ed213c90c7d", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "37808-126", "generic_name": "levocetirizine dihydrochloride", "labeler_name": "HEB", "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": "20190615", "listing_expiration_date": "20271231"}