NDC 49999-552

benzonatate

Benzonatate

benzonatate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Benzonatate.

Product ID49999-552_d5f6ab45-dc2c-459e-8c48-db861223e10d
NDC49999-552
Product TypeHuman Prescription Drug
Proprietary Namebenzonatate
Generic NameBenzonatate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2007-07-25
Marketing CategoryANDA / ANDA
Application NumberANDA040749
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameBENZONATATE
Active Ingredient Strength200 mg/1
Pharm ClassesDecreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 49999-552-20

20 CAPSULE in 1 BOTTLE (49999-552-20)
Marketing Start Date2014-01-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49999-552-15 [49999055215]

benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040749
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-24
Marketing End Date2014-12-31

NDC 49999-552-20 [49999055220]

benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040749
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-24
Marketing End Date2019-10-11

NDC 49999-552-60 [49999055260]

benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040749
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-24
Marketing End Date2017-06-01

NDC 49999-552-30 [49999055230]

benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040749
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-24
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
BENZONATATE200 mg/1

OpenFDA Data

SPL SET ID:9905b730-3560-44bc-92cc-705f0c6f6b15
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283417
  • 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.