benzonatate

Generic: benzonatate

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler ascend laboratories, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 200 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-575
Product ID 67877-575_c4c367db-c1ef-4b68-b373-987b36e51f50
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040627
Listing Expiration 2026-12-31
Marketing Start 2017-03-22

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 67877575
Hyphenated Format 67877-575

Supplemental Identifiers

RxCUI
197397 283417
UNII
5P4DHS6ENR
NUI
N0000009010 N0000175796

Packaging Origin

Original Packager
true

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
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (67877-575-01)
  • 500 CAPSULE in 1 BOTTLE (67877-575-05)
source: ndc

Packages (2)

67877-575-01 100 CAPSULE in 1 BOTTLE (67877-575-01) 67877-575-05 500 CAPSULE in 1 BOTTLE (67877-575-05)

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": "c4c367db-c1ef-4b68-b373-987b36e51f50", "openfda": {"nui": ["N0000009010", "N0000175796"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397", "283417"], "spl_set_id": ["54374c04-63b9-49fa-b6a2-4a711e322d8e"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (67877-575-01)", "package_ndc": "67877-575-01", "marketing_start_date": "20170322"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (67877-575-05)", "package_ndc": "67877-575-05", "marketing_start_date": "20170322"}], "brand_name": "BENZONATATE", "product_id": "67877-575_c4c367db-c1ef-4b68-b373-987b36e51f50", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "67877-575", "generic_name": "BENZONATATE", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BENZONATATE", "active_ingredients": [{"name": "BENZONATATE", "strength": "200 mg/1"}], "application_number": "ANDA040627", "marketing_category": "ANDA", "marketing_start_date": "20170322", "listing_expiration_date": "20261231"}