benzonatate

Generic: benzonatate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler major pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 100 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7153
Product ID 0904-7153_a9e81d1d-28ad-422e-9d41-088638605086
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206948
Listing Expiration 2026-12-31
Marketing Start 2018-12-21

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 09047153
Hyphenated Format 0904-7153

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 ANDA206948 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7153-61) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7153-61 100 BLISTER PACK in 1 CARTON (0904-7153-61) / 1 CAPSULE in 1 BLISTER PACK

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": "a9e81d1d-28ad-422e-9d41-088638605086", "openfda": {"nui": ["N0000009010", "N0000175796"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397"], "spl_set_id": ["324f65ae-09d1-4bd6-9d2b-593035201ecd"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7153-61)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7153-61", "marketing_start_date": "20181221"}], "brand_name": "Benzonatate", "product_id": "0904-7153_a9e81d1d-28ad-422e-9d41-088638605086", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "0904-7153", "generic_name": "Benzonatate", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "100 mg/1"}], "application_number": "ANDA206948", "marketing_category": "ANDA", "marketing_start_date": "20181221", "listing_expiration_date": "20261231"}