benzonatate

Generic: benzonatate

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler northwind health company, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 100 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-754
Product ID 51655-754_49516954-2f3a-7b4a-e063-6394a90a3fa4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206948
Listing Expiration 2027-12-31
Marketing Start 2021-07-15

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 51655754
Hyphenated Format 51655-754

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
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-20)
  • 21 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-21)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-52)
  • 15 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-54)
  • 9 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-85)
source: ndc

Packages (5)

51655-754-20 20 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-20) 51655-754-21 21 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-21) 51655-754-52 30 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-52) 51655-754-54 15 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-54) 51655-754-85 9 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-85)

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": "49516954-2f3a-7b4a-e063-6394a90a3fa4", "openfda": {"nui": ["N0000009010", "N0000175796"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397"], "spl_set_id": ["da6bcd14-2294-e7df-e053-2995a90a4526"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-20)", "package_ndc": "51655-754-20", "marketing_start_date": "20210715"}, {"sample": false, "description": "21 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-21)", "package_ndc": "51655-754-21", "marketing_start_date": "20230531"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-52)", "package_ndc": "51655-754-52", "marketing_start_date": "20221005"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-54)", "package_ndc": "51655-754-54", "marketing_start_date": "20221130"}, {"sample": false, "description": "9 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-85)", "package_ndc": "51655-754-85", "marketing_start_date": "20231221"}], "brand_name": "Benzonatate", "product_id": "51655-754_49516954-2f3a-7b4a-e063-6394a90a3fa4", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "51655-754", "generic_name": "Benzonatate", "labeler_name": "Northwind Health Company, LLC", "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": "20210715", "listing_expiration_date": "20271231"}