benzonatate

Generic: benzonatate

Labeler: preferred pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler preferred pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 200 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8336
Product ID 68788-8336_c3a2e422-b252-4a08-ac8c-f5fb214152be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211518
Listing Expiration 2026-12-31
Marketing Start 2023-04-06

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 687888336
Hyphenated Format 68788-8336

Supplemental Identifiers

RxCUI
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 ANDA211518 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 15 CAPSULE in 1 BOTTLE (68788-8336-1)
  • 20 CAPSULE in 1 BOTTLE (68788-8336-2)
  • 30 CAPSULE in 1 BOTTLE (68788-8336-3)
  • 60 CAPSULE in 1 BOTTLE (68788-8336-6)
source: ndc

Packages (4)

68788-8336-1 15 CAPSULE in 1 BOTTLE (68788-8336-1) 68788-8336-2 20 CAPSULE in 1 BOTTLE (68788-8336-2) 68788-8336-3 30 CAPSULE in 1 BOTTLE (68788-8336-3) 68788-8336-6 60 CAPSULE in 1 BOTTLE (68788-8336-6)

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": "c3a2e422-b252-4a08-ac8c-f5fb214152be", "openfda": {"nui": ["N0000009010", "N0000175796"], "unii": ["5P4DHS6ENR"], "rxcui": ["283417"], "spl_set_id": ["fe5e8a94-ac75-4657-a45a-1fe94dbe0d43"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "15 CAPSULE in 1 BOTTLE (68788-8336-1)", "package_ndc": "68788-8336-1", "marketing_start_date": "20230406"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (68788-8336-2)", "package_ndc": "68788-8336-2", "marketing_start_date": "20230406"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68788-8336-3)", "package_ndc": "68788-8336-3", "marketing_start_date": "20230406"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (68788-8336-6)", "package_ndc": "68788-8336-6", "marketing_start_date": "20230406"}], "brand_name": "Benzonatate", "product_id": "68788-8336_c3a2e422-b252-4a08-ac8c-f5fb214152be", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "68788-8336", "generic_name": "Benzonatate", "labeler_name": "Preferred Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "200 mg/1"}], "application_number": "ANDA211518", "marketing_category": "ANDA", "marketing_start_date": "20230406", "listing_expiration_date": "20261231"}