NDC 72865-119

Benzonatate

Benzonatate

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

Product ID72865-119_7e08a1cb-6d75-42ee-8388-eb7dc73fa2a9
NDC72865-119
Product TypeHuman Prescription Drug
Proprietary NameBenzonatate
Generic NameBenzonatate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-02-17
Marketing CategoryANDA / ANDA
Application NumberANDA211518
Labeler NameXLCare Pharmaceuticals, Inc
Substance NameBENZONATATE
Active Ingredient Strength200 mg/1
Pharm ClassesDecreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 72865-119-01

100 CAPSULE in 1 BOTTLE (72865-119-01)
Marketing Start Date2020-02-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72865-119-30 [72865011930]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA211518
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-17

NDC 72865-119-01 [72865011901]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA211518
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-17

NDC 72865-119-05 [72865011905]

Benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA211518
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-17

Drug Details

Active Ingredients

IngredientStrength
BENZONATATE200 mg/1

OpenFDA Data

SPL SET ID:e33afd96-5ad3-4033-b067-981ac2ed2bea
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 903291
  • 197397
  • 283417
  • UPC Code
  • 0372865119051
  • 0372865117057
  • 0372865118054
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.