Basic Information
Omeprazole
55111-644
Regulatory Information
55111-644
ANDA078490
C73584
April 20, 2023
USA
These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. INITIAL U.S. APPROVAL: 1989
HUMAN PRESCRIPTION DRUG LABEL
29
Company Information
650562841
Active Ingredients
glyceryl monostearate
Code: 230OU9XXE4
Class Code: IACT
meglumine
Code: 6HG8UB2MUY
Class Code: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
Code: NX76LV5T8J
Class Code: IACT
RAW SUGAR
Code: 8M707QY5GH
Class Code: IACT
POLOXAMER 407
Code: TUF2IVW3M2
Class Code: IACT
talc
Code: 7SEV7J4R1U
Class Code: IACT
titanium dioxide
Code: 15FIX9V2JP
Class Code: IACT
D&C Red No. 28
Code: 767IP0Y5NH
Class Code: IACT
triethyl citrate
Code: 8Z96QXD6UM
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
POTASSIUM HYDROXIDE
Code: WZH3C48M4T
Class Code: IACT
gelatin
Code: 2G86QN327L
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
propylene glycol
Code: 6DC9Q167V3
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
hypromelloses
Code: 3NXW29V3WO
Class Code: IACT
Active Moieties
Omeprazole
Code: KG60484QX9