Acebutolol Hydrochloride (Page 4 of 4)

Ventricular Arrhythmia

The usual initial dose of acebutolol is 400 mg daily given as 200 mg b.i.d. Dosage should be increased gradually until an optimal clinical response is obtained, generally at 600 to 1200 mg per day. If treatment is to be discontinued, the dosage should be reduced gradually over a period of about two weeks.

Use in Older Patients

Older patients have an approximately 2-fold increase in bioavailability and may require lower maintenance doses. Doses above 800 mg/day should be avoided in the elderly.

HOW SUPPLIED

Acebutolol hydrochloride capsules, USP are available as follows:

200 mg: Hard gelatin capsules with bright orange opaque body printed radially “669” with black ink and lavender opaque cap printed radially “Amneal” with black ink.

Bottles of 100 NDC 10135-0630-01

400 mg: Hard gelatin capsules with bright orange opaque body printed radially “670” with black ink and lavender opaque cap printed radially “Amneal” with black ink.

Bottles of 100 NDC 10135-0631-01

Keep tightly closed.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container.

Manufactured for and Distributed by:

Marlex Pharmaceuticals
New Castle, DE 19720

Rev. 10/2017AN

PRINCIPAL DISPLAY PANEL

NDC 10135-0630-01
Acebutolol
Hydrochloride
Capsules, USP
200 mg
100 CAPSULES
Rx Only

PRINCIPAL DISPLAY PANEL
NDC 10135-0630-01
Acebutolol 
Hydrochloride
Capsules, USP
200 mg
100 CAPSULES
Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 10135-0631-01
Acebutolol
Hydrochloride
Capsules, USP
400 mg
100 CAPSULES
Rx Only

PRINCIPAL DISPLAY PANEL
NDC 10135-0631-01
Acebutolol 
Hydrochloride
Capsules, USP
400 mg
100 CAPSULES
Rx Only
(click image for full-size original)
ACEBUTOLOL HYDROCHLORIDE
acebutolol hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-630
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACEBUTOLOL HYDROCHLORIDE (ACEBUTOLOL) ACEBUTOLOL 200 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
STARCH, CORN
POVIDONE
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color purple (Lavender Opaque Cap) , orange (Bright Orange Opaque body) Score no score
Shape CAPSULE (Hard Gelatin) Size 18mm
Flavor Imprint Code 669;Amneal
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-630-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075047 10/20/2017
ACEBUTOLOL HYDROCHLORIDE
acebutolol hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-631
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACEBUTOLOL HYDROCHLORIDE (ACEBUTOLOL) ACEBUTOLOL 400 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
STARCH, CORN
POVIDONE
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color purple (Lavender Opaque Cap) , orange (Bright Orange Opaque Body) Score no score
Shape CAPSULE (Hard Gelatin) Size 23mm
Flavor Imprint Code 670;Amneal
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-631-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075047 10/20/2017
Labeler — Marlex Pharmaceuticals Inc (782540215)

Revised: 09/2021 Marlex Pharmaceuticals Inc

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