Clomipramine Hydrochloride (Page 10 of 10)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 25 mg Strength

NDC 52817-280-10
100 Capsules
clomiPRAMINE Hydrochloride Capsules, USP
25 mg Rx only
Pharmacist: Please dispense with attached medication guide
TULEX Pharmaceuticals

LA2801000300 04/2020

Lot:
Exp:

USUAL DOSAGE: See package insert .
STORAGE: Store at 20 °C to 25 °C (68 °F to 77 °F) [see USP Controlled Room Temperature].
Dispense in well-closed containers with a child-resistant closure. Protect from moisture.
Do not accept if seal over bottle opening is broken or missing.

Each capsule contains:
Clomipramine Hydrochloride USP … 25 mg

Manufactured by
Tulex Pharmaceuticals Inc. Cranbury, NJ 08512

Distributed By:

TruPharma, LLC

Tampa, FL33609

Clomipramine HCl Capsules USP 25 mg
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 50 mg Strength

NDC 52817-281-10
100 Capsules

clomiPRAMINE Hydrochloride Capsules, USP
50 mg Rx only
Pharmacist: Please dispense with attached medication guide
TULEX Pharmaceuticals

LA2811000300 04/2020

Lot:
Exp:

USUAL DOSAGE: See package insert .
STORAGE: Store at 20 °C to 25 °C (68 °F to 77 °F) [see USP Controlled Room Temperature].
Dispense in well-closed containers with a child-resistant closure. Protect from moisture.
Do not accept if seal over bottle opening is broken or missing.

Each capsule contains:
Clomipramine Hydrochloride USP …50 mg

Manufactured by
Tulex Pharmaceuticals Inc.
Cranbury, NJ 08512

Distributed By:

TruPharma, LLC

Tampa, FL33609

Clomipramine HCl Capsules 50 mg
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 75 mg Strength

NDC 52817-282-10
100 Capsules

clomiPRAMINE Hydrochloride Capsules, USP
75 mg Rx only


Pharmacist: Please dispense with attached medication guide
TULEX Pharmaceuticals

LA2821000300 04/2020

Lot:
Exp:

USUAL DOSAGE: See package insert .
STORAGE: Store at 20 °C to 25 °C (68 °F to 77 °F) [see USP Controlled Room Temperature].
Dispense in well-closed containers with a child-resistant closure. Protect from moisture.
Do not accept if seal over bottle opening is broken or missing.

Each capsule contains:
Clomipramine Hydrochloride USP …75 mg

Manufactured by
Tulex Pharmaceuticals Inc. Cranbury, NJ 08512

Distributed By:

TruPharma, LLC

Tampa, FL33609

Clomipramine HCl Capsules USP 75 mg
(click image for full-size original)
CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-280
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
TITANIUM DIOXIDE
SILICON DIOXIDE
FD&C BLUE NO. 1
STARCH, CORN
FD&C RED NO. 3
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN
MAGNESIUM STEARATE
Product Characteristics
Color white (ivory) , orange (orange) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code T280
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-280-10 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210653 09/01/2020
CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-281
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
STARCH, CORN
TITANIUM DIOXIDE
SILICON DIOXIDE
FD&C RED NO. 3
Product Characteristics
Color white (ivory) , blue (light blue) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code T281
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-281-10 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210653 09/01/2020
CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-282
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 75 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
TITANIUM DIOXIDE
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN
MAGNESIUM STEARATE
Product Characteristics
Color white (ivory) , yellow (yellow) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code T282
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-282-10 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210653 09/01/2020
Labeler — TruPharma LLC (078533947)
Registrant — Tulex Pharmaceuticals, Inc. (080119240)

Revised: 11/2022 TruPharma LLC

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 © 2024. All Rights Reserved.