NDC Code(s) : 64380-841-06, 64380-841-11
Packager : Strides Pharma Science Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

diclofenac potassium diclofenac potassium CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-841
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC POTASSIUM(UNII: L4D5UA6CB4)
(DICLOFENAC - UNII:144O8QL0L1) 		DICLOFENAC POTASSIUM25 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROCHLORIC ACID(UNII: QTT17582CB)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
NONCRYSTALLIZING SORBITOL SOLUTION(UNII: 9E0S3UM200)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K30(UNII: U725QWY32X)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code 25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64380-841-06100 in 1 BOTTLE Type 0: Not a Combination Product20/09/2022
2NDC:64380-841-11120 in 1 BOTTLE Type 0: Not a Combination Product28/12/2024
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210078 09/20/2022

LABELER - Strides Pharma Science Limited(650738743)

PRINCIPAL DISPLAY PANEL

NDC 64380-841-06

100 Liquid Filled Capsules

Rx Only

Diclofenac Potassium Capsules

25 mg

Marketed by: Strides Pharma Inc.

25 mg 100-count Bottle Label

NDC 64380-841-11

120 Liquid Filled Capsules

Rx Only

Diclofenac Potassium Capsules

25 mg

Marketed by: Strides Pharma Inc.

25 mg 100-count Bottle Label