NDC 43386-999

cevimeline hydrochloride

Cevimeline Hydrochloride

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

Product ID43386-999_231fb8b5-e1b6-4ef7-bc2c-e895eea40b0d
NDC43386-999
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 NameLupin Pharmaceuticals,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 43386-999-01

100 CAPSULE in 1 BOTTLE (43386-999-01)
Marketing Start Date2016-12-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43386-999-01 [43386099901]

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

NDC 43386-999-05 [43386099905]

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

NDC 43386-999-03 [43386099903]

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:0fbcf1a7-5b8b-42fb-b764-4b529e7d1a99
Manufacturer
UNII
UPC Code
  • 0343386999057

    • 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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