benzonatate

Generic: benzonatate

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

benzonatate 100 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-536
Product ID 65162-536_72b0f799-3f8f-4dcf-9c6e-57e796996a80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040682
Listing Expiration 2026-12-31
Marketing Start 2010-06-04

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 65162536
Hyphenated Format 65162-536

Supplemental Identifiers

RxCUI
197397 283417
UPC
0365162537505 0365162536508
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 ANDA040682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-536-10)
  • 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-536-50)
source: ndc

Packages (2)

65162-536-10 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-536-10) 65162-536-50 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-536-50)

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": "72b0f799-3f8f-4dcf-9c6e-57e796996a80", "openfda": {"nui": ["N0000009010", "N0000175796"], "upc": ["0365162537505", "0365162536508"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397", "283417"], "spl_set_id": ["199a42ae-4d19-4e68-934d-dabd27084988"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-536-10)", "package_ndc": "65162-536-10", "marketing_start_date": "20100604"}, {"sample": false, "description": "500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-536-50)", "package_ndc": "65162-536-50", "marketing_start_date": "20100604"}], "brand_name": "Benzonatate", "product_id": "65162-536_72b0f799-3f8f-4dcf-9c6e-57e796996a80", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "65162-536", "generic_name": "Benzonatate", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "100 mg/1"}], "application_number": "ANDA040682", "marketing_category": "ANDA", "marketing_start_date": "20100604", "listing_expiration_date": "20261231"}