NDC 70518-0008

Benzonatate

Benzonatate

Benzonatate is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Benzonatate.

Product ID70518-0008_814f3600-df9e-7257-e053-2a91aa0aa2a7
NDC70518-0008
Product TypeHuman Prescription Drug
Proprietary NameBenzonatate
Generic NameBenzonatate
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-11-18
Marketing CategoryANDA / ANDA
Application NumberANDA040682
Labeler NameREMEDYREPACK INC.
Substance NameBENZONATATE
Active Ingredient Strength100 mg/1
Pharm ClassesDecreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0008-3

10 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70518-0008-3)
Marketing Start Date2017-02-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0008-1 [70518000801]

Benzonatate CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA040682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-22
Marketing End Date2018-10-04

NDC 70518-0008-2 [70518000802]

Benzonatate CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA040682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-11
Marketing End Date2018-04-21

NDC 70518-0008-3 [70518000803]

Benzonatate CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA040682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-06
Marketing End Date2018-08-18

NDC 70518-0008-0 [70518000800]

Benzonatate CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA040682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-18
Marketing End Date2016-11-21

Drug Details

Active Ingredients

IngredientStrength
BENZONATATE100 mg/1

OpenFDA Data

SPL SET ID:a3c86774-a3e3-4d10-822b-4567dde7b858
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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