NDC 53002-5890

benzonatate

Benzonatate

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

Product ID53002-5890_3f27c36a-0e92-4f79-9111-ebe4e17315fd
NDC53002-5890
Product TypeHuman Prescription Drug
Proprietary Namebenzonatate
Generic NameBenzonatate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-03-22
Marketing CategoryANDA / ANDA
Application NumberANDA040627
Labeler NameRPK Pharmaceuticals, 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 53002-5890-1

10 CAPSULE in 1 BOTTLE (53002-5890-1)
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-5890-5 [53002589005]

benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040627
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-5890-1 [53002589001]

benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040627
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-5890-2 [53002589002]

benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040627
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-5890-3 [53002589003]

benzonatate CAPSULE
Marketing CategoryANDA
Application NumberANDA040627
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BENZONATATE100 mg/1

OpenFDA Data

SPL SET ID:6d2c40f7-dae1-4a37-9b4b-8c5926c747f6
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.