NDC 35356-863

Benzonatate

Benzonatate

Benzonatate is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Benzonatate.

Product ID35356-863_ce3a3e93-7e63-4ba8-826e-3e09d6eee68d
NDC35356-863
Product TypeHuman Prescription Drug
Proprietary NameBenzonatate
Generic NameBenzonatate
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2010-06-04
Marketing CategoryANDA / ANDA
Application NumberANDA040682
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameBENZONATATE
Active Ingredient Strength100 mg/1
Pharm ClassesDecreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 35356-863-30

30 CAPSULE, LIQUID FILLED in 1 BOTTLE (35356-863-30)
Marketing Start Date2010-06-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-863-30 [35356086330]

Benzonatate CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA040682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-06-04
Marketing End Date2019-10-11

NDC 35356-863-20 [35356086320]

Benzonatate CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA040682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-06-04
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
BENZONATATE100 mg/1

OpenFDA Data

SPL SET ID:2a154b2c-2719-48da-b3fb-b16e6c4d956a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197397
  • Pharmacological Class

    • Decreased Tracheobronchial Stretch Receptor Activity [PE]
    • Non-narcotic Antitussive [EPC]

    NDC Crossover Matching brand name "Benzonatate" or generic name "Benzonatate"

    NDCBrand NameGeneric Name
    0179-0237benzonatatebenzonatate
    0440-1185benzonatatebenzonatate
    0440-5185benzonatatebenzonatate
    0440-5186benzonatatebenzonatate
    0440-5187benzonatatebenzonatate
    0440-7185benzonatatebenzonatate
    0440-7186benzonatatebenzonatate
    0615-1349BenzonatateBenzonatate
    0615-7678BenzonatateBenzonatate
    0615-7887benzonatatebenzonatate
    0615-8143benzonatatebenzonatate
    0615-8194benzonatatebenzonatate
    0615-8403BenzonatateBenzonatate
    0904-5904benzonatatebenzonatate
    0904-5905benzonatatebenzonatate
    0904-6564BenzonatateBenzonatate
    0904-6657benzonatatebenzonatate
    0904-7153BenzonatateBenzonatate
    10135-632BenzonatateBenzonatate
    10544-094benzonatatebenzonatate
    10544-123benzonatatebenzonatate
    10544-129benzonatatebenzonatate
    11788-027benzonatatebenzonatate
    11788-028benzonatatebenzonatate
    11788-029benzonatatebenzonatate
    67877-128benzonatatebenzonatate
    67877-105benzonatatebenzonatate
    67877-106benzonatatebenzonatate
    67877-575benzonatatebenzonatate
    67877-574benzonatatebenzonatate
    67877-573benzonatatebenzonatate
    68071-1891benzonatatebenzonatate
    68071-1984benzonatatebenzonatate
    68071-3185benzonatatebenzonatate
    68071-1877BenzonatateBenzonatate
    68071-3204benzonatatebenzonatate
    68071-3346benzonatatebenzonatate
    68071-4317benzonatatebenzonatate
    68071-4105BenzonatateBenzonatate
    68071-4258benzonatatebenzonatate
    68071-4337benzonatatebenzonatate
    68071-4276benzonatatebenzonatate
    68151-2697BenzonatateBenzonatate
    68382-247BenzonatateBenzonatate
    68382-248BenzonatateBenzonatate
    68788-6357BenzonatateBenzonatate
    68788-7014BenzonatateBenzonatate
    68788-6839BenzonatateBenzonatate
    68788-7087benzonatatebenzonatate
    68788-7094benzonatatebenzonatate

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