NDC 71626-201

Benzonatate

Benzonatate

Benzonatate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Medstone Pharma Llc. The primary component is Benzonatate.

Product ID71626-201_c958b35a-11a8-406b-9168-4e51bd29a4fe
NDC71626-201
Product TypeHuman Prescription Drug
Proprietary NameBenzonatate
Generic NameBenzonatate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA202765
Labeler NameMedstone Pharma 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 71626-201-01

100 CAPSULE in 1 BOTTLE (71626-201-01)
Marketing Start Date2018-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71626-201-01 [71626020101]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA202765
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-31
Inactivation Date2020-01-31
Reactivation Date2020-03-20

NDC 71626-201-05 [71626020105]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA202765
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-31
Inactivation Date2020-01-31
Reactivation Date2020-03-20

Drug Details

Active Ingredients

IngredientStrength
BENZONATATE100 mg/1

OpenFDA Data

SPL SET ID:d58b2044-918c-4626-815f-957530611495
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197397
    • UPC Code
  • 0371626201011

    • 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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