benzonatate

Generic: benzonatate

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

benzonatate 100 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-5105
Product ID 68071-5105_1b469ff6-52eb-a91b-e063-6394a90a3123
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA081297
Listing Expiration 2026-12-31
Marketing Start 2016-08-15

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 680715105
Hyphenated Format 68071-5105

Supplemental Identifiers

RxCUI
197397
UPC
0368071510546
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 ANDA081297 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 4 CAPSULE in 1 BOTTLE (68071-5105-4)
source: ndc

Packages (1)

68071-5105-4 4 CAPSULE in 1 BOTTLE (68071-5105-4)

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": "1b469ff6-52eb-a91b-e063-6394a90a3123", "openfda": {"nui": ["N0000009010", "N0000175796"], "upc": ["0368071510546"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397"], "spl_set_id": ["96b260c3-e177-73c3-e053-2a95a90a775e"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "4 CAPSULE in 1 BOTTLE (68071-5105-4)", "package_ndc": "68071-5105-4", "marketing_start_date": "20191106"}], "brand_name": "Benzonatate", "product_id": "68071-5105_1b469ff6-52eb-a91b-e063-6394a90a3123", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "68071-5105", "generic_name": "Benzonatate", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "100 mg/1"}], "application_number": "ANDA081297", "marketing_category": "ANDA", "marketing_start_date": "20160815", "listing_expiration_date": "20261231"}