benzonatate

Generic: benzonatate

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler zydus pharmaceuticals usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 100 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-247
Product ID 68382-247_52dc3ff3-f01b-4820-ba1e-b043a5b2c49a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040597
Listing Expiration 2026-12-31
Marketing Start 2007-04-09

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 68382247
Hyphenated Format 68382-247

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 ANDA040597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68382-247-01)
  • 500 CAPSULE in 1 BOTTLE (68382-247-05)
source: ndc

Packages (2)

68382-247-01 100 CAPSULE in 1 BOTTLE (68382-247-01) 68382-247-05 500 CAPSULE in 1 BOTTLE (68382-247-05)

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": "52dc3ff3-f01b-4820-ba1e-b043a5b2c49a", "openfda": {"nui": ["N0000009010", "N0000175796"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397", "283417"], "spl_set_id": ["331c70dc-005e-4d96-a35c-4d2d810aa3b1"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68382-247-01)", "package_ndc": "68382-247-01", "marketing_start_date": "20070409"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (68382-247-05)", "package_ndc": "68382-247-05", "marketing_start_date": "20070409"}], "brand_name": "Benzonatate", "product_id": "68382-247_52dc3ff3-f01b-4820-ba1e-b043a5b2c49a", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "68382-247", "generic_name": "Benzonatate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "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": "20070409", "listing_expiration_date": "20261231"}