benzonatate

Generic: benzonatate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

benzonatate 100 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-230
Product ID 72789-230_2d6c8457-a91d-08a1-e063-6294a90a2807
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 72789230
Hyphenated Format 72789-230

Supplemental Identifiers

RxCUI
197397
UPC
0372789230122
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
  • 6 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-06)
  • 12 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-12)
  • 15 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-15)
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-20)
  • 21 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-21)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-30)
source: ndc

Packages (6)

72789-230-06 6 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-06) 72789-230-12 12 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-12) 72789-230-15 15 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-15) 72789-230-20 20 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-20) 72789-230-21 21 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-21) 72789-230-30 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-30)

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": "2d6c8457-a91d-08a1-e063-6294a90a2807", "openfda": {"nui": ["N0000009010", "N0000175796"], "upc": ["0372789230122"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397"], "spl_set_id": ["70e157f2-1670-422c-a70d-f9576e1647ea"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-06)", "package_ndc": "72789-230-06", "marketing_start_date": "20220816"}, {"sample": false, "description": "12 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-12)", "package_ndc": "72789-230-12", "marketing_start_date": "20220721"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-15)", "package_ndc": "72789-230-15", "marketing_start_date": "20220202"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-20)", "package_ndc": "72789-230-20", "marketing_start_date": "20220216"}, {"sample": false, "description": "21 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-21)", "package_ndc": "72789-230-21", "marketing_start_date": "20220202"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-30)", "package_ndc": "72789-230-30", "marketing_start_date": "20220202"}], "brand_name": "Benzonatate", "product_id": "72789-230_2d6c8457-a91d-08a1-e063-6294a90a2807", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "72789-230", "generic_name": "Benzonatate", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}