CEVIMELINE HYDROCHLORIDE

Product NDC
71335-2326
11-digit product format
713352326
Labeler code
71335
Product ID
71335-2326_2fcca18a-cdb5-4a3c-a861-6042764347d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEVIMELINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA216682
Marketing category
ANDA
Marketing start
2023-04-06
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
2027-12-31
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
71335-2326-17133523260130 CAPSULE in 1 BOTTLE, PLASTIC (71335-2326-1) 30 capsule2024-01-08NoNoHistorical
71335-2326-27133523260260 CAPSULE in 1 BOTTLE, PLASTIC (71335-2326-2) 60 capsule2024-01-08NoNoHistorical
71335-2326-37133523260390 CAPSULE in 1 BOTTLE, PLASTIC (71335-2326-3) 90 capsule2024-01-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cevimeline hydrochloride Capsules 30mgBryant Ranch Prepack2026-05-15HUMAN PRESCRIPTION DRUG LABEL101