NDC 70518-0930

benzonatate

Benzonatate

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

Product ID70518-0930_6857e013-571f-22da-e053-2a91aa0aad45
NDC70518-0930
Product TypeHuman Prescription Drug
Proprietary Namebenzonatate
Generic NameBenzonatate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-01-05
Marketing CategoryANDA / ANDA
Application NumberANDA040627
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 Through2019-12-31

Packaging

NDC 70518-0930-0

30 CAPSULE in 1 BOTTLE, PLASTIC (70518-0930-0)
Marketing Start Date2018-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0930-2 [70518093002]

benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040627
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-23
Marketing End Date2020-05-15

NDC 70518-0930-1 [70518093001]

benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040627
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-01

NDC 70518-0930-0 [70518093000]

benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040627
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-05

Drug Details

Active Ingredients

IngredientStrength
BENZONATATE100 mg/1

OpenFDA Data

SPL SET ID:58204634-0d3d-4b63-89c6-86cd899ae8db
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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