Basic Information
Dicyclomine Hydrochloride
55289-923
Regulatory Information
55289-923
ANDA085082
C73584
April 12, 2023
USA
These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE. DICYCLOMINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1950
HUMAN PRESCRIPTION DRUG LABEL
30
Company Information
156893695
Active Ingredients
Inactive Ingredients
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
D&C RED NO. 28
Code: 767IP0Y5NH
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
GELATIN
Code: 2G86QN327L
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
Active Moieties
DICYCLOMINE
Code: 4KV4X8IF6V