benzonatate

Generic: benzonatate

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

benzonatate 100 mg/1

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 61919-400
Product ID 61919-400_2e5c46d0-92ba-9396-e063-6294a90a1f79
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040597
Listing Expiration 2026-12-31
Marketing Start 2018-03-12

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 61919400
Hyphenated Format 61919-400

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 ANDA040597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 20 CAPSULE in 1 BOTTLE (61919-400-20)
  • 30 CAPSULE in 1 BOTTLE (61919-400-30)
source: ndc

Packages (2)

61919-400-20 20 CAPSULE in 1 BOTTLE (61919-400-20) 61919-400-30 30 CAPSULE in 1 BOTTLE (61919-400-30)

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": "2e5c46d0-92ba-9396-e063-6294a90a1f79", "openfda": {"nui": ["N0000009010", "N0000175796"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397"], "spl_set_id": ["673bf826-a005-7a38-e053-2991aa0a4cb5"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": "20 CAPSULE in 1 BOTTLE (61919-400-20)", "package_ndc": "61919-400-20", "marketing_start_date": "20180312"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (61919-400-30)", "package_ndc": "61919-400-30", "marketing_start_date": "20180312"}], "brand_name": "BENZONATATE", "product_id": "61919-400_2e5c46d0-92ba-9396-e063-6294a90a1f79", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "61919-400", "generic_name": "BENZONATATE", "labeler_name": "DIRECT RX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BENZONATATE", "active_ingredients": [{"name": "BENZONATATE", "strength": "100 mg/1"}], "application_number": "ANDA040597", "marketing_category": "ANDA", "marketing_start_date": "20180312", "listing_expiration_date": "20261231"}