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 50090-5409
Product ID 50090-5409_351ba2ac-be0c-4273-bc32-fa70e90b883d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206948
Listing Expiration 2026-12-31
Marketing Start 2018-12-21

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 500905409
Hyphenated Format 50090-5409

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 ANDA206948 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 20 CAPSULE in 1 BOTTLE (50090-5409-0)
  • 24 CAPSULE in 1 BOTTLE (50090-5409-1)
  • 30 CAPSULE in 1 BOTTLE (50090-5409-2)
  • 15 CAPSULE in 1 BOTTLE (50090-5409-5)
source: ndc

Packages (4)

50090-5409-0 20 CAPSULE in 1 BOTTLE (50090-5409-0) 50090-5409-1 24 CAPSULE in 1 BOTTLE (50090-5409-1) 50090-5409-2 30 CAPSULE in 1 BOTTLE (50090-5409-2) 50090-5409-5 15 CAPSULE in 1 BOTTLE (50090-5409-5)

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": "351ba2ac-be0c-4273-bc32-fa70e90b883d", "openfda": {"nui": ["N0000009010", "N0000175796"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397"], "spl_set_id": ["e6f5f2c2-1c59-405c-97bf-ee73740869d2"], "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": "20 CAPSULE in 1 BOTTLE (50090-5409-0)", "package_ndc": "50090-5409-0", "marketing_start_date": "20201215"}, {"sample": false, "description": "24 CAPSULE in 1 BOTTLE (50090-5409-1)", "package_ndc": "50090-5409-1", "marketing_start_date": "20201215"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (50090-5409-2)", "package_ndc": "50090-5409-2", "marketing_start_date": "20201215"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE (50090-5409-5)", "package_ndc": "50090-5409-5", "marketing_start_date": "20201215"}], "brand_name": "Benzonatate", "product_id": "50090-5409_351ba2ac-be0c-4273-bc32-fa70e90b883d", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "50090-5409", "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": "ANDA206948", "marketing_category": "ANDA", "marketing_start_date": "20181221", "listing_expiration_date": "20261231"}