Label: CEVIMELINE HYDROCHLORIDE capsule
- NDC Code(s): 70771-1982-1
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 16, 2026
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INGREDIENTS AND APPEARANCE
CEVIMELINE HYDROCHLORIDE
cevimeline hydrochloride capsuleProduct 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)
