Duloxetine Delayed-Release (Page 13 of 13)

PRINCIPAL DISPLAY PANEL — 40 mg Capsule Bottle Label

NDC 68001-368-04

Duloxetine
Delayed-Release Capsules, USP

40 mg

PHARMACIST: Dispense the Medication
Guide provided separately to each patient.

BluePoint Laboratories.

Rx Only30 Capsules

Duloxetine Label rev 03 2020
(click image for full-size original)
DULOXETINE DELAYED-RELEASE duloxetine hydrochloride capsule, delayed release pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-368
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE (DULOXETINE) DULOXETINE 40 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
TALC
TITANIUM DIOXIDE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
SODIUM LAURYL SULFATE
POLYSORBATE 80
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
SHELLAC
SUCROSE
STARCH, CORN
GELATIN, UNSPECIFIED
FD&C BLUE NO. 2
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color ORANGE, BLUE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code B;750
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-368-04 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203088 11/16/2018
Labeler — BluePoint Laboratories (985523874)
Registrant — Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Esteve Pharmaceuticals, S.A. 460940853 MANUFACTURE (68001-368)

Revised: 04/2020 BluePoint Laboratories

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.