CEVIMELINE HYDROCHLORIDE capsule

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cevimeline Hydrochloride Capsules, 30 mg

NDC: 70771-1982-1 in bottles of 100 capsules with child resistant-closure

Rx Only

INGREDIENTS AND APPEARANCE

CEVIMELINE HYDROCHLORIDE 
cevimeline hydrochloride capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1982
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CEVIMELINE HYDROCHLORIDE (UNII: P81Q6V85NP) (CEVIMELINE - UNII:K9V0CDQ56E)	CEVIMELINE HYDROCHLORIDE ANHYDROUS	30 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE (20000 WAMW) (UNII: KZQ570MOA5)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)
SHELLAC (UNII: 46N107B71O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Product Characteristics
Color	WHITE (WHITE OPAQUE)	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	1964
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1982-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA220267	04/15/2026

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Pharmaceuticals Limited (650173735)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Pharmaceuticals Limited		650173735	ANALYSIS(70771-1982) , MANUFACTURE(70771-1982)