benzonatate

Generic: benzonatate

Labeler: redpharm drug
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler redpharm drug
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 100 mg/1

Manufacturer
Redpharm Drug

Identifiers & Regulatory

Product NDC 67296-2194
Product ID 67296-2194_44f297cf-d3c4-dd3c-e063-6394a90ac577
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202765
Listing Expiration 2026-12-31
Marketing Start 2024-07-26

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 672962194
Hyphenated Format 67296-2194

Supplemental Identifiers

RxCUI
197397
UPC
0364980634014 0364980635011
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 ANDA202765 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 15 CAPSULE in 1 BOTTLE (67296-2194-1)
source: ndc

Packages (1)

67296-2194-1 15 CAPSULE in 1 BOTTLE (67296-2194-1)

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": "44f297cf-d3c4-dd3c-e063-6394a90ac577", "openfda": {"nui": ["N0000009010", "N0000175796"], "upc": ["0364980634014", "0364980635011"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397"], "spl_set_id": ["44f2826e-20ff-b53c-e063-6394a90a9630"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Redpharm Drug"]}, "finished": true, "packaging": [{"sample": false, "description": "15 CAPSULE in 1 BOTTLE (67296-2194-1)", "package_ndc": "67296-2194-1", "marketing_start_date": "20240726"}], "brand_name": "Benzonatate", "product_id": "67296-2194_44f297cf-d3c4-dd3c-e063-6394a90ac577", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "67296-2194", "generic_name": "Benzonatate", "labeler_name": "Redpharm Drug", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "100 mg/1"}], "application_number": "ANDA202765", "marketing_category": "ANDA", "marketing_start_date": "20240726", "listing_expiration_date": "20261231"}