benzonatate

Generic: benzonatate

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler zydus lifesciences limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 200 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-843
Product ID 65841-843_fb123061-e971-4394-aa10-ae733de31be1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040597
Listing Expiration 2026-12-31
Marketing Start 2007-09-04

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 65841843
Hyphenated Format 65841-843

Supplemental Identifiers

RxCUI
197397 283417
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 ANDA040597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (65841-843-01)
source: ndc

Packages (1)

65841-843-01 100 CAPSULE in 1 BOTTLE (65841-843-01)

Ingredients (1)

benzonatate (200 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": "fb123061-e971-4394-aa10-ae733de31be1", "openfda": {"nui": ["N0000009010", "N0000175796"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397", "283417"], "spl_set_id": ["abb4360a-4c52-45b6-9b80-df3c1bfc4c59"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (65841-843-01)", "package_ndc": "65841-843-01", "marketing_start_date": "20070904"}], "brand_name": "Benzonatate", "product_id": "65841-843_fb123061-e971-4394-aa10-ae733de31be1", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "65841-843", "generic_name": "Benzonatate", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "200 mg/1"}], "application_number": "ANDA040597", "marketing_category": "ANDA", "marketing_start_date": "20070904", "listing_expiration_date": "20261231"}