benzonatate

Generic: benzonatate

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 200 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-635
Product ID 64980-635_4bbf8d39-1a31-43e3-a656-cf98fe991be9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202765
Listing Expiration 2026-12-31
Marketing Start 2024-07-26

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 64980635
Hyphenated Format 64980-635

Supplemental Identifiers

RxCUI
197397 283417
UPC
0364980634014 0364980635011
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 ANDA202765 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (64980-635-01)
  • 500 CAPSULE in 1 BOTTLE (64980-635-50)
source: ndc

Packages (2)

64980-635-01 100 CAPSULE in 1 BOTTLE (64980-635-01) 64980-635-50 500 CAPSULE in 1 BOTTLE (64980-635-50)

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": "4bbf8d39-1a31-43e3-a656-cf98fe991be9", "openfda": {"nui": ["N0000009010", "N0000175796"], "upc": ["0364980634014", "0364980635011"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397", "283417"], "spl_set_id": ["0ca22f92-9750-4eb4-8cdb-ebd3b12691cc"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (64980-635-01)", "package_ndc": "64980-635-01", "marketing_start_date": "20240726"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (64980-635-50)", "package_ndc": "64980-635-50", "marketing_start_date": "20240726"}], "brand_name": "Benzonatate", "product_id": "64980-635_4bbf8d39-1a31-43e3-a656-cf98fe991be9", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "64980-635", "generic_name": "Benzonatate", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "200 mg/1"}], "application_number": "ANDA202765", "marketing_category": "ANDA", "marketing_start_date": "20240726", "listing_expiration_date": "20261231"}