benzonatate

Generic: benzonatate

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler asclemed usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 200 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-804
Product ID 76420-804_3306a754-a59a-d003-e063-6294a90a65c9
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 76420804
Hyphenated Format 76420-804

Supplemental Identifiers

RxCUI
197397 283417
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
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (76420-804-01)
  • 500 CAPSULE in 1 BOTTLE (76420-804-05)
  • 20 CAPSULE in 1 BOTTLE (76420-804-20)
  • 30 CAPSULE in 1 BOTTLE (76420-804-30)
  • 60 CAPSULE in 1 BOTTLE (76420-804-60)
  • 90 CAPSULE in 1 BOTTLE (76420-804-90)
source: ndc

Packages (6)

76420-804-01 100 CAPSULE in 1 BOTTLE (76420-804-01) 76420-804-05 500 CAPSULE in 1 BOTTLE (76420-804-05) 76420-804-20 20 CAPSULE in 1 BOTTLE (76420-804-20) 76420-804-30 30 CAPSULE in 1 BOTTLE (76420-804-30) 76420-804-60 60 CAPSULE in 1 BOTTLE (76420-804-60) 76420-804-90 90 CAPSULE in 1 BOTTLE (76420-804-90)

Ingredients (1)

benzonatate (200 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": "3306a754-a59a-d003-e063-6294a90a65c9", "openfda": {"nui": ["N0000009010", "N0000175796"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397", "283417"], "spl_set_id": ["25ed5206-b322-486f-9e54-14125f6e74c5"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (76420-804-01)", "package_ndc": "76420-804-01", "marketing_start_date": "20240429"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (76420-804-05)", "package_ndc": "76420-804-05", "marketing_start_date": "20240429"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (76420-804-20)", "package_ndc": "76420-804-20", "marketing_start_date": "20250418"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-804-30)", "package_ndc": "76420-804-30", "marketing_start_date": "20240429"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-804-60)", "package_ndc": "76420-804-60", "marketing_start_date": "20240429"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-804-90)", "package_ndc": "76420-804-90", "marketing_start_date": "20240429"}], "brand_name": "Benzonatate", "product_id": "76420-804_3306a754-a59a-d003-e063-6294a90a65c9", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "76420-804", "generic_name": "Benzonatate", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "200 mg/1"}], "application_number": "ANDA206948", "marketing_category": "ANDA", "marketing_start_date": "20181221", "listing_expiration_date": "20261231"}