desloratadine

Generic: desloratadine

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desloratadine
Generic Name desloratadine
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

desloratadine 5 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3975
Product ID 50090-3975_435e054f-b898-4718-90d6-cfa9f98077f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078355
Listing Expiration 2026-12-31
Marketing Start 2015-06-12

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 500903975
Hyphenated Format 50090-3975

Supplemental Identifiers

RxCUI
349420
UNII
FVF865388R
NUI
N0000000190 N0000175587

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 ANDA078355 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (50090-3975-0)
  • 30 TABLET in 1 BOTTLE (50090-3975-1)
source: ndc

Packages (2)

50090-3975-0 90 TABLET in 1 BOTTLE (50090-3975-0) 50090-3975-1 30 TABLET in 1 BOTTLE (50090-3975-1)

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": "435e054f-b898-4718-90d6-cfa9f98077f9", "openfda": {"nui": ["N0000000190", "N0000175587"], "unii": ["FVF865388R"], "rxcui": ["349420"], "spl_set_id": ["36307c2b-6b6a-46a9-9fe4-1798fc72e7b8"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-3975-0)", "package_ndc": "50090-3975-0", "marketing_start_date": "20181213"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-3975-1)", "package_ndc": "50090-3975-1", "marketing_start_date": "20181206"}], "brand_name": "Desloratadine", "product_id": "50090-3975_435e054f-b898-4718-90d6-cfa9f98077f9", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50090-3975", "generic_name": "Desloratadine", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desloratadine", "active_ingredients": [{"name": "DESLORATADINE", "strength": "5 mg/1"}], "application_number": "ANDA078355", "marketing_category": "ANDA", "marketing_start_date": "20150612", "listing_expiration_date": "20261231"}