fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

Labeler: granules india ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler granules india ltd
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 60 mg/1

Manufacturer
Granules India Ltd

Identifiers & Regulatory

Product NDC 62207-765
Product ID 62207-765_3b98f58b-cf16-dcd8-e063-6394a90a8b01
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211075
Listing Expiration 2026-12-31
Marketing Start 2020-12-18

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 62207765
Hyphenated Format 62207-765

Supplemental Identifiers

RxCUI
997420 997501
UPC
0362207766517 0362207765510
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 fexofenadine hydrochloride (source: ndc)
Generic Name fexofenadine hydrochloride (source: ndc)
Application Number ANDA211075 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (62207-765-49)
  • 1 BOTTLE in 1 CARTON (62207-765-51) / 10 TABLET in 1 BOTTLE
  • 8 BLISTER PACK in 1 CARTON (62207-765-60) / 9 TABLET in 1 BLISTER PACK
  • 5 POUCH in 1 BOX (62207-765-88) / 10000 TABLET in 1 POUCH
source: ndc

Packages (4)

62207-765-49 1000 TABLET in 1 BOTTLE (62207-765-49) 62207-765-51 1 BOTTLE in 1 CARTON (62207-765-51) / 10 TABLET in 1 BOTTLE 62207-765-60 8 BLISTER PACK in 1 CARTON (62207-765-60) / 9 TABLET in 1 BLISTER PACK 62207-765-88 5 POUCH in 1 BOX (62207-765-88) / 10000 TABLET in 1 POUCH

Ingredients (1)

fexofenadine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Fexofenadine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b98f58b-cf16-dcd8-e063-6394a90a8b01", "openfda": {"upc": ["0362207766517", "0362207765510"], "unii": ["2S068B75ZU"], "rxcui": ["997420", "997501"], "spl_set_id": ["3151bc6d-b40b-4200-a5cf-e57b6791d92a"], "manufacturer_name": ["Granules India Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (62207-765-49)", "package_ndc": "62207-765-49", "marketing_start_date": "20201218"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (62207-765-51)  / 10 TABLET in 1 BOTTLE", "package_ndc": "62207-765-51", "marketing_start_date": "20201218"}, {"sample": false, "description": "8 BLISTER PACK in 1 CARTON (62207-765-60)  / 9 TABLET in 1 BLISTER PACK", "package_ndc": "62207-765-60", "marketing_start_date": "20201218"}, {"sample": false, "description": "5 POUCH in 1 BOX (62207-765-88)  / 10000 TABLET in 1 POUCH", "package_ndc": "62207-765-88", "marketing_start_date": "20211117"}], "brand_name": "Fexofenadine Hydrochloride", "product_id": "62207-765_3b98f58b-cf16-dcd8-e063-6394a90a8b01", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "62207-765", "generic_name": "Fexofenadine Hydrochloride", "labeler_name": "Granules India Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine Hydrochloride", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA211075", "marketing_category": "ANDA", "marketing_start_date": "20201218", "listing_expiration_date": "20261231"}