benzonatate

Generic: benzonatate

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 100 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8403
Product ID 0615-8403_0a50d6e0-6aa7-4dd0-88e3-86d91298c7e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091133
Listing Expiration 2026-12-31
Marketing Start 2016-12-10

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 06158403
Hyphenated Format 0615-8403

Supplemental Identifiers

RxCUI
197397
UNII
5P4DHS6ENR
NUI
N0000009010 N0000175796

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 ANDA091133 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 15 CAPSULE in 1 BLISTER PACK (0615-8403-05)
  • 21 CAPSULE in 1 BLISTER PACK (0615-8403-21)
  • 30 CAPSULE in 1 BLISTER PACK (0615-8403-39)
source: ndc

Packages (3)

0615-8403-05 15 CAPSULE in 1 BLISTER PACK (0615-8403-05) 0615-8403-21 21 CAPSULE in 1 BLISTER PACK (0615-8403-21) 0615-8403-39 30 CAPSULE in 1 BLISTER PACK (0615-8403-39)

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": "0a50d6e0-6aa7-4dd0-88e3-86d91298c7e2", "openfda": {"nui": ["N0000009010", "N0000175796"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397"], "spl_set_id": ["6f5c19ad-d811-4196-a9c3-4f6b89626b83"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 CAPSULE in 1 BLISTER PACK (0615-8403-05)", "package_ndc": "0615-8403-05", "marketing_start_date": "20240703"}, {"sample": false, "description": "21 CAPSULE in 1 BLISTER PACK (0615-8403-21)", "package_ndc": "0615-8403-21", "marketing_start_date": "20240212"}, {"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (0615-8403-39)", "package_ndc": "0615-8403-39", "marketing_start_date": "20211006"}], "brand_name": "Benzonatate", "product_id": "0615-8403_0a50d6e0-6aa7-4dd0-88e3-86d91298c7e2", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "0615-8403", "generic_name": "Benzonatate", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "100 mg/1"}], "application_number": "ANDA091133", "marketing_category": "ANDA", "marketing_start_date": "20161210", "listing_expiration_date": "20261231"}