NDC 40032-999

cevimeline hydrochloride

Cevimeline Hydrochloride

cevimeline hydrochloride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novel Laboratories, Inc.. The primary component is Cevimeline Hydrochloride.

Product ID40032-999_c42fae45-bbcf-40b6-911d-ebe3893f10ba
NDC40032-999
Product TypeHuman Prescription Drug
Proprietary Namecevimeline hydrochloride
Generic NameCevimeline Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-12-30
Marketing CategoryANDA / ANDA
Application NumberANDA204746
Labeler NameNovel Laboratories, Inc.
Substance NameCEVIMELINE HYDROCHLORIDE
Active Ingredient Strength30 mg/1
Pharm ClassesCholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 40032-999-01

100 CAPSULE in 1 BOTTLE (40032-999-01)
Marketing Start Date2016-12-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 40032-999-05 [40032099905]

cevimeline hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA204746
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-30

NDC 40032-999-03 [40032099903]

cevimeline hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA204746
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-30

NDC 40032-999-01 [40032099901]

cevimeline hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA204746
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-30

Drug Details

Active Ingredients

IngredientStrength
CEVIMELINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:d7432a48-1142-431e-997f-8419dc724824
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309140
    • UPC Code
  • 0340032999058
  • 0340032999010
  • 0340032999034

    • Pharmacological Class

    • Cholinergic Muscarinic Agonists [MoA]
    • Cholinergic Receptor Agonist [EPC]
    • Cholinergic Muscarinic Agonists [MoA]
    • Cholinergic Receptor Agonist [EPC]

    NDC Crossover Matching brand name "cevimeline hydrochloride" or generic name "Cevimeline Hydrochloride"

    NDCBrand NameGeneric Name
    0054-0334Cevimeline HydrochlorideCevimeline Hydrochloride
    0713-0937cevimeline hydrochloridecevimeline hydrochloride
    16571-657Cevimeline HydrochlorideCevimeline Hydrochloride
    40032-999cevimeline hydrochloridecevimeline hydrochloride
    43386-999cevimeline hydrochloridecevimeline hydrochloride
    0713-0883Evoxaccevimeline hydrochloride
    63395-201Evoxaccevimeline hydrochloride
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