Basic Information
Diclofenac Sodium
76420-572
Regulatory Information
76420-572
ANDA090066
C73584
March 6, 2024
USA
Diclofenac Sodium Delayed-release Tablets, USP 25 mg, 50 mg and 75 mg
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
059888437
Active Ingredients
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
MICROCRYSTALLINE CELLULOSE 101
Code: 7T9FYH5QMK
Class Code: IACT
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
POVIDONE
Code: FZ989GH94E
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
Code: NX76LV5T8J
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
POLYETHYLENE GLYCOL 6000
Code: 30IQX730WE
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
Active Moieties
DICLOFENAC
Code: 144O8QL0L1