benzonatate

Generic: benzonatate

Labeler: xlcare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler xlcare pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 100 mg/1

Manufacturer
XLCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72865-117
Product ID 72865-117_ff2c1e5b-32ee-4c36-bf70-6aa9df252b01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211518
Listing Expiration 2026-12-31
Marketing Start 2020-02-17

Pharmacologic Class

Established (EPC)
non-narcotic antitussive [epc]
Physiologic Effect
decreased tracheobronchial stretch receptor activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72865117
Hyphenated Format 72865-117

Supplemental Identifiers

RxCUI
197397 283417 903291
UPC
0372865119013 0372865117309 0372865117019 0372865118306 0372865118016 0372865119303
UNII
5P4DHS6ENR
NUI
N0000009010 N0000175796

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 benzonatate (source: ndc)
Generic Name benzonatate (source: ndc)
Application Number ANDA211518 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (72865-117-01)
  • 500 CAPSULE in 1 BOTTLE (72865-117-05)
  • 30 CAPSULE in 1 BOTTLE (72865-117-30)
source: ndc

Packages (3)

72865-117-01 100 CAPSULE in 1 BOTTLE (72865-117-01) 72865-117-05 500 CAPSULE in 1 BOTTLE (72865-117-05) 72865-117-30 30 CAPSULE in 1 BOTTLE (72865-117-30)

Ingredients (1)

benzonatate (100 mg/1)

Linked Drug Pages (1)

Benzonatate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ff2c1e5b-32ee-4c36-bf70-6aa9df252b01", "openfda": {"nui": ["N0000009010", "N0000175796"], "upc": ["0372865119013", "0372865117309", "0372865117019", "0372865118306", "0372865118016", "0372865119303"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397", "283417", "903291"], "spl_set_id": ["e33afd96-5ad3-4033-b067-981ac2ed2bea"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["XLCare Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (72865-117-01)", "package_ndc": "72865-117-01", "marketing_start_date": "20200217"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (72865-117-05)", "package_ndc": "72865-117-05", "marketing_start_date": "20200217"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72865-117-30)", "package_ndc": "72865-117-30", "marketing_start_date": "20200217"}], "brand_name": "Benzonatate", "product_id": "72865-117_ff2c1e5b-32ee-4c36-bf70-6aa9df252b01", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "72865-117", "generic_name": "Benzonatate", "labeler_name": "XLCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "100 mg/1"}], "application_number": "ANDA211518", "marketing_category": "ANDA", "marketing_start_date": "20200217", "listing_expiration_date": "20261231"}