childrens allergy

Generic: fexofenadine hydrochloride

Labeler: h2-pharma, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens allergy
Generic Name fexofenadine hydrochloride
Labeler h2-pharma, llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 30 mg/5mL

Manufacturer
H2-Pharma, LLC

Identifiers & Regulatory

Product NDC 61269-527
Product ID 61269-527_33920aab-2fdc-44ed-b36d-0d759a9bcd94
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA203330
Listing Expiration 2026-12-31
Marketing Start 2022-07-18

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 61269527
Hyphenated Format 61269-527

Supplemental Identifiers

RxCUI
997491
UNII
2S068B75ZU

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 childrens allergy (source: ndc)
Generic Name fexofenadine hydrochloride (source: ndc)
Application Number ANDA203330 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (61269-527-94) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

61269-527-94 1 BOTTLE in 1 CARTON (61269-527-94) / 118 mL in 1 BOTTLE

Ingredients (1)

fexofenadine hydrochloride (30 mg/5mL)

Linked Drug Pages (1)

Childrens Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "33920aab-2fdc-44ed-b36d-0d759a9bcd94", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997491"], "spl_set_id": ["84988f6d-85b1-45dd-89be-0333acc6b180"], "manufacturer_name": ["H2-Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (61269-527-94)  / 118 mL in 1 BOTTLE", "package_ndc": "61269-527-94", "marketing_start_date": "20220718"}], "brand_name": "Childrens Allergy", "product_id": "61269-527_33920aab-2fdc-44ed-b36d-0d759a9bcd94", "dosage_form": "SUSPENSION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "61269-527", "generic_name": "fexofenadine hydrochloride", "labeler_name": "H2-Pharma, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Allergy", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "30 mg/5mL"}], "application_number": "ANDA203330", "marketing_category": "ANDA", "marketing_start_date": "20220718", "listing_expiration_date": "20261231"}