childrens allergy

Generic: fexofenadine hcl

Labeler: equate (wal-mart stores, inc.) (see also wal-mart inc)
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens allergy
Generic Name fexofenadine hcl
Labeler equate (wal-mart stores, inc.) (see also wal-mart inc)
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 30 mg/5mL

Manufacturer
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)

Identifiers & Regulatory

Product NDC 49035-208
Product ID 49035-208_b407f021-be2e-4c6e-aef6-583778b4681b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA203330
Listing Expiration 2026-12-31
Marketing Start 2020-07-01

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 49035208
Hyphenated Format 49035-208

Supplemental Identifiers

RxCUI
997491
UPC
0681131378710
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 hcl (source: ndc)
Application Number ANDA203330 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (49035-208-04) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

49035-208-04 1 BOTTLE, PLASTIC in 1 CARTON (49035-208-04) / 118 mL in 1 BOTTLE, PLASTIC

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": "b407f021-be2e-4c6e-aef6-583778b4681b", "openfda": {"upc": ["0681131378710"], "unii": ["2S068B75ZU"], "rxcui": ["997491"], "spl_set_id": ["667c87c2-c594-49e5-92a7-f8aa140642d6"], "manufacturer_name": ["EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (49035-208-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "49035-208-04", "marketing_start_date": "20200701"}], "brand_name": "Childrens Allergy", "product_id": "49035-208_b407f021-be2e-4c6e-aef6-583778b4681b", "dosage_form": "SUSPENSION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "49035-208", "generic_name": "Fexofenadine HCL", "labeler_name": "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "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": "20200701", "listing_expiration_date": "20261231"}