Cevimeline Hydrochloride

Product NDC
72162-2563
11-digit product format
721622563
Labeler code
72162
Product ID
72162-2563_fb360aef-a237-424f-95a0-f39d33113bd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cevimeline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215056
Marketing category
ANDA
Marketing start
2023-04-18
Substance
CEVIMELINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
P81Q6V85NPCEVIMELINE HYDROCHLORIDE153504-70-2CEVIMELINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2563-172162256301100 CAPSULE in 1 BOTTLE (72162-2563-1) 100 capsule2025-11-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cevimeline Hydrochloride Capsules Rx onlyBryant Ranch Prepack2025-11-04HUMAN PRESCRIPTION DRUG LABEL100