levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-5107
Product ID 68071-5107_1b469ff6-52ec-a91b-e063-6394a90a3123
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202046
Listing Expiration 2026-12-31
Marketing Start 2013-09-30

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 680715107
Hyphenated Format 68071-5107

Supplemental Identifiers

RxCUI
855172
UPC
0368071510799
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 ANDA202046 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (68071-5107-9)
source: ndc

Packages (1)

68071-5107-9 90 TABLET, FILM COATED in 1 BOTTLE (68071-5107-9)

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": "1b469ff6-52ec-a91b-e063-6394a90a3123", "openfda": {"upc": ["0368071510799"], "unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["97a67686-7e94-dd77-e053-2995a90a42c6"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68071-5107-9)", "package_ndc": "68071-5107-9", "marketing_start_date": "20191118"}], "brand_name": "Levocetirizine Dihydrochloride", "product_id": "68071-5107_1b469ff6-52ec-a91b-e063-6394a90a3123", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68071-5107", "generic_name": "levocetirizine Dihydrochloride", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levocetirizine Dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA202046", "marketing_category": "ANDA", "marketing_start_date": "20130930", "listing_expiration_date": "20261231"}