desloratadine oral solution (74157-011)

Drug Facts

Product Profile

Brand Name desloratadine oral solution

Generic Name desloratadine

Labeler ina pharmaceutics, inc.

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

desloratadine .5 mg/mL

Manufacturer

INA Pharmaceutics, Inc.

Identifiers & Regulatory

Product NDC 74157-011

Product ID 74157-011_41d5e0d4-6189-847b-e063-6294a90a2e2f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202936

Listing Expiration 2026-12-31

Marketing Start 2025-07-01

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 74157011

Hyphenated Format 74157-011

Supplemental Identifiers

RxCUI

607573

UPC

0374157011012

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 oral solution (source: ndc)

Generic Name desloratadine (source: ndc)

Application Number ANDA202936 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

.5 mg/mL

source: ndc

Packaging

118 mL in 1 BOTTLE (74157-011-01)

source: ndc

Packages (1)

74157-011-01 118 mL in 1 BOTTLE (74157-011-01)

Ingredients (1)

desloratadine (.5 mg/mL)

Linked Drug Pages (1)

Desloratadine Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "41d5e0d4-6189-847b-e063-6294a90a2e2f", "openfda": {"nui": ["N0000000190", "N0000175587"], "upc": ["0374157011012"], "unii": ["FVF865388R"], "rxcui": ["607573"], "spl_set_id": ["41d5e0d4-6188-847b-e063-6294a90a2e2f"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["INA Pharmaceutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (74157-011-01)", "package_ndc": "74157-011-01", "marketing_start_date": "20250701"}], "brand_name": "Desloratadine Oral Solution", "product_id": "74157-011_41d5e0d4-6189-847b-e063-6294a90a2e2f", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "74157-011", "generic_name": "Desloratadine", "labeler_name": "INA Pharmaceutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desloratadine Oral Solution", "active_ingredients": [{"name": "DESLORATADINE", "strength": ".5 mg/mL"}], "application_number": "ANDA202936", "marketing_category": "ANDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}