benzonatate

Generic: benzonatate

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler chartwell rx, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 100 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-440
Product ID 62135-440_f8703b53-c89b-9014-e053-6294a90a4006
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040682
Listing Expiration 2026-12-31
Marketing Start 2018-05-01

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 62135440
Hyphenated Format 62135-440

Supplemental Identifiers

RxCUI
197397 283417
UPC
0362135440015 0362135441319 0362135440312 0362135441609 0362135440909
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 ANDA040682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (62135-440-01)
  • 300 CAPSULE in 1 BOTTLE (62135-440-31)
  • 90 CAPSULE in 1 BOTTLE (62135-440-90)
source: ndc

Packages (3)

62135-440-01 100 CAPSULE in 1 BOTTLE (62135-440-01) 62135-440-31 300 CAPSULE in 1 BOTTLE (62135-440-31) 62135-440-90 90 CAPSULE in 1 BOTTLE (62135-440-90)

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": "f8703b53-c89b-9014-e053-6294a90a4006", "openfda": {"nui": ["N0000009010", "N0000175796"], "upc": ["0362135440015", "0362135441319", "0362135440312", "0362135441609", "0362135440909"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397", "283417"], "spl_set_id": ["8a17033c-1ad3-4c7a-92ee-f55756833986"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (62135-440-01)", "package_ndc": "62135-440-01", "marketing_start_date": "20230322"}, {"sample": false, "description": "300 CAPSULE in 1 BOTTLE (62135-440-31)", "package_ndc": "62135-440-31", "marketing_start_date": "20230105"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (62135-440-90)", "package_ndc": "62135-440-90", "marketing_start_date": "20230105"}], "brand_name": "Benzonatate", "product_id": "62135-440_f8703b53-c89b-9014-e053-6294a90a4006", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "62135-440", "generic_name": "Benzonatate", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "100 mg/1"}], "application_number": "ANDA040682", "marketing_category": "ANDA", "marketing_start_date": "20180501", "listing_expiration_date": "20261231"}