benzonatate

Generic: benzonatate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler proficient rx lp
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 100 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-016
Product ID 63187-016_b81d0eb4-1112-4371-aa8b-afa80ff03ab5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040627
Listing Expiration 2026-12-31
Marketing Start 2007-07-25

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 63187016
Hyphenated Format 63187-016

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 ANDA040627 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE (63187-016-10)
  • 15 CAPSULE in 1 BOTTLE (63187-016-15)
  • 20 CAPSULE in 1 BOTTLE (63187-016-20)
  • 30 CAPSULE in 1 BOTTLE (63187-016-30)
  • 40 CAPSULE in 1 BOTTLE (63187-016-40)
source: ndc

Packages (5)

63187-016-10 10 CAPSULE in 1 BOTTLE (63187-016-10) 63187-016-15 15 CAPSULE in 1 BOTTLE (63187-016-15) 63187-016-20 20 CAPSULE in 1 BOTTLE (63187-016-20) 63187-016-30 30 CAPSULE in 1 BOTTLE (63187-016-30) 63187-016-40 40 CAPSULE in 1 BOTTLE (63187-016-40)

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": "b81d0eb4-1112-4371-aa8b-afa80ff03ab5", "openfda": {"nui": ["N0000009010", "N0000175796"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397", "283417"], "spl_set_id": ["18a633e8-c285-49ce-88dd-1f46b140e4d4"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE (63187-016-10)", "package_ndc": "63187-016-10", "marketing_start_date": "20170901"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE (63187-016-15)", "package_ndc": "63187-016-15", "marketing_start_date": "20140401"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (63187-016-20)", "package_ndc": "63187-016-20", "marketing_start_date": "20140401"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (63187-016-30)", "package_ndc": "63187-016-30", "marketing_start_date": "20150401"}, {"sample": false, "description": "40 CAPSULE in 1 BOTTLE (63187-016-40)", "package_ndc": "63187-016-40", "marketing_start_date": "20161101"}], "brand_name": "benzonatate", "product_id": "63187-016_b81d0eb4-1112-4371-aa8b-afa80ff03ab5", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "63187-016", "generic_name": "benzonatate", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "100 mg/1"}], "application_number": "ANDA040627", "marketing_category": "ANDA", "marketing_start_date": "20070725", "listing_expiration_date": "20261231"}