benzonatate

Generic: benzonatate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 100 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-692
Product ID 71610-692_48b92534-e189-4b18-906f-8a4abcb776a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA081297
Listing Expiration 2026-12-31
Marketing Start 2017-01-18

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 71610692
Hyphenated Format 71610-692

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 ANDA081297 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-30)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-53)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-60)
source: ndc

Packages (3)

71610-692-30 30 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-30) 71610-692-53 60 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-53) 71610-692-60 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-60)

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": "48b92534-e189-4b18-906f-8a4abcb776a4", "openfda": {"nui": ["N0000009010", "N0000175796"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397"], "spl_set_id": ["3bd33aec-9a30-4581-bd28-6cfb67772cef"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-30)", "package_ndc": "71610-692-30", "marketing_start_date": "20230310"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-53)", "package_ndc": "71610-692-53", "marketing_start_date": "20230310"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-60)", "package_ndc": "71610-692-60", "marketing_start_date": "20230310"}], "brand_name": "Benzonatate", "product_id": "71610-692_48b92534-e189-4b18-906f-8a4abcb776a4", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "71610-692", "generic_name": "Benzonatate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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": "20170118", "listing_expiration_date": "20261231"}