benzonatate

Generic: benzonatate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler a-s medication solutions
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 100 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4968
Product ID 50090-4968_307aec37-9f24-4b15-84e0-c679d4d26643
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202765
Listing Expiration 2026-12-31
Marketing Start 2017-09-07

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 500904968
Hyphenated Format 50090-4968

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 ANDA202765 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 15 CAPSULE in 1 BOTTLE (50090-4968-0)
source: ndc

Packages (1)

50090-4968-0 15 CAPSULE in 1 BOTTLE (50090-4968-0)

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": "307aec37-9f24-4b15-84e0-c679d4d26643", "openfda": {"nui": ["N0000009010", "N0000175796"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397"], "spl_set_id": ["36c3f916-cc4e-4e09-8419-4d6b64157e32"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "15 CAPSULE in 1 BOTTLE (50090-4968-0)", "package_ndc": "50090-4968-0", "marketing_start_date": "20210917"}], "brand_name": "Benzonatate", "product_id": "50090-4968_307aec37-9f24-4b15-84e0-c679d4d26643", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "50090-4968", "generic_name": "Benzonatate", "labeler_name": "A-S Medication Solutions", "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": "20170907", "listing_expiration_date": "20261231"}