NDC 71335-0091

Benzonatate

Benzonatate

Benzonatate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Benzonatate.

Product ID71335-0091_c8fe9520-15dd-422f-9b26-bd7bda4997e3
NDC71335-0091
Product TypeHuman Prescription Drug
Proprietary NameBenzonatate
Generic NameBenzonatate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2007-04-09
Marketing CategoryANDA / ANDA
Application NumberANDA040597
Labeler NameBryant Ranch Prepack
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 71335-0091-5

120 CAPSULE in 1 BOTTLE (71335-0091-5)
Marketing Start Date2013-02-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0091-1 [71335009101]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040597
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-30
Marketing End Date2019-04-30

NDC 71335-0091-9 [71335009109]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040597
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-30
Marketing End Date2019-04-30

NDC 71335-0091-3 [71335009103]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040597
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-30
Marketing End Date2019-04-30

NDC 71335-0091-2 [71335009102]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040597
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-30
Marketing End Date2019-04-30

NDC 71335-0091-0 [71335009100]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-30
Marketing End Date2019-04-30

NDC 71335-0091-6 [71335009106]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040597
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-30
Marketing End Date2019-04-30

NDC 71335-0091-5 [71335009105]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040597
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-30
Marketing End Date2019-04-30

NDC 71335-0091-8 [71335009108]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040597
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-30
Marketing End Date2019-04-30

NDC 71335-0091-7 [71335009107]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040597
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-30
Marketing End Date2019-04-30

NDC 71335-0091-4 [71335009104]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040597
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-30
Marketing End Date2019-04-30

Drug Details

Active Ingredients

IngredientStrength
BENZONATATE100 mg/1

OpenFDA Data

SPL SET ID:751d9d60-cd6b-4aa1-b68f-61b86c4059ad
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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