desloratadine

Generic: desloratadine

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

Drug Facts

Product Profile

Brand Name desloratadine
Generic Name desloratadine
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

desloratadine 5 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-153
Product ID 68180-153_816c977e-5e34-42e0-ba3d-c8060f8cfa17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078352
Listing Expiration 2026-12-31
Marketing Start 2013-02-25

Pharmacologic Class

Established (EPC)
histamine-1 receptor antagonist [epc]
Mechanism of Action
histamine h1 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180153
Hyphenated Format 68180-153

Supplemental Identifiers

RxCUI
349420
UPC
0368180153023 0368180153016
UNII
FVF865388R
NUI
N0000000190 N0000175587

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 desloratadine (source: ndc)
Generic Name desloratadine (source: ndc)
Application Number ANDA078352 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68180-153-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (68180-153-02)
source: ndc

Packages (2)

68180-153-01 100 TABLET, FILM COATED in 1 BOTTLE (68180-153-01) 68180-153-02 500 TABLET, FILM COATED in 1 BOTTLE (68180-153-02)

Ingredients (1)

desloratadine (5 mg/1)

Linked Drug Pages (1)

DESLORATADINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "816c977e-5e34-42e0-ba3d-c8060f8cfa17", "openfda": {"nui": ["N0000000190", "N0000175587"], "upc": ["0368180153023", "0368180153016"], "unii": ["FVF865388R"], "rxcui": ["349420"], "spl_set_id": ["2a90b899-7746-43dc-ac8a-e754428eb30c"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68180-153-01)", "package_ndc": "68180-153-01", "marketing_start_date": "20130225"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68180-153-02)", "package_ndc": "68180-153-02", "marketing_start_date": "20130225"}], "brand_name": "DESLORATADINE", "product_id": "68180-153_816c977e-5e34-42e0-ba3d-c8060f8cfa17", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68180-153", "generic_name": "DESLORATADINE", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DESLORATADINE", "active_ingredients": [{"name": "DESLORATADINE", "strength": "5 mg/1"}], "application_number": "ANDA078352", "marketing_category": "ANDA", "marketing_start_date": "20130225", "listing_expiration_date": "20261231"}