Basic Information
Diclofenac Sodium and Misoprostol
0591-0398
Regulatory Information
0591-0398
ANDA201089
C73584
January 31, 2023
USA
These highlights do not include all the information needed to use DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS . DICLOFENAC SODIUM and MISOPROSTOL delayed-release tablets, for oral use Initial U.S. Approval: 1997
HUMAN PRESCRIPTION DRUG LABEL
34
Company Information
119723554
Active Ingredients
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
CROSPOVIDONE
Code: 2S7830E561
Class Code: IACT
HYDROGENATED CASTOR OIL
Code: ZF94AP8MEY
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
POVIDONE K30
Code: U725QWY32X
Class Code: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
Code: NX76LV5T8J
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
SODIUM HYDROXIDE
Code: 55X04QC32I
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
Active Moieties
DICLOFENAC
Code: 144O8QL0L1
MISOPROSTOL
Code: 0E43V0BB57