benzonatate

Generic: benzonatate

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler bionpharma inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 100 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-143
Product ID 69452-143_407f50b2-8640-399e-e063-6294a90a4e2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA081297
Listing Expiration 2026-12-31
Marketing Start 2016-08-15

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 69452143
Hyphenated Format 69452-143

Supplemental Identifiers

RxCUI
197397 283417
UPC
0369452143209
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 ANDA081297 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (69452-143-20)
  • 500 CAPSULE in 1 BOTTLE, PLASTIC (69452-143-30)
source: ndc

Packages (2)

69452-143-20 100 CAPSULE in 1 BOTTLE, PLASTIC (69452-143-20) 69452-143-30 500 CAPSULE in 1 BOTTLE, PLASTIC (69452-143-30)

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": "407f50b2-8640-399e-e063-6294a90a4e2a", "openfda": {"nui": ["N0000009010", "N0000175796"], "upc": ["0369452143209"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397", "283417"], "spl_set_id": ["2630be01-1d2d-4c40-8e56-8568ea89eacf"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (69452-143-20)", "package_ndc": "69452-143-20", "marketing_start_date": "20160815"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (69452-143-30)", "package_ndc": "69452-143-30", "marketing_start_date": "20160815"}], "brand_name": "Benzonatate", "product_id": "69452-143_407f50b2-8640-399e-e063-6294a90a4e2a", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "69452-143", "generic_name": "Benzonatate", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "100 mg/1"}], "application_number": "ANDA081297", "marketing_category": "ANDA", "marketing_start_date": "20160815", "listing_expiration_date": "20261231"}