Diltiazem Hydrochloride (Page 4 of 4)

HOW SUPPLIED

Diltiazem hydrochloride 30 mg tablets are supplied in bottles of 100 (NDC 42799-129-01)and 500 (NDC 42799-129-02). Light green, round, biconvex, film coated tablet, debossed with ‘͡ ‘ above ‘129’ on one side and plain on the other side.

Diltiazem hydrochloride 60 mg scored tablets are supplied in bottles of 100 (NDC 42799-130-01) and 500 (NDC 42799-130-02). Light yellow, round, biconvex, film coated, scored tablet, debossed with ‘͡ ‘ above an indent and ‘130’ below the indent on one side and scored on the other side

Diltiazem hydrochloride 90 mg scored tablets are supplied in bottles of 100 (NDC 42799-131-01) and 500 (NDC 42799-131-02). Light green, capsule shaped, film coated, scored tablet debossed with ‘͡ ‘ above ‘131’ on one side and scored on the other side.

Diltiazem hydrochloride 120 mg scored tablets are supplied in bottles of 100 (NDC 42799-132-01). Light yellow, capsule shaped, film coated, scored tablet, debossed with ‘͡ ‘ above ‘132’ on one side and scored on the other side.
Store at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid excessive humidity.
Dispense in light-resistant, tight container with child-resistant closure.
Manufactured for:
Edenbridge Pharmaceuticals, LLC
Parsippany, NJ 07054
877-381-3336
Rev. 05/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 100
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30 500
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60mg100ct
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60mg500ct
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90mg100ct
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90mg500ct
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120mg100ct
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DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42799-129
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 129
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42799-129-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:42799-129-02 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211596 10/29/2018
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42799-130
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 60 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYDROXYPROPYL CELLULOSE
HYPROMELLOSE, UNSPECIFIED
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 12mm
Flavor Imprint Code 130
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42799-130-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:42799-130-02 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211596 10/29/2018
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42799-131
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 90 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
HYDROXYPROPYL CELLULOSE
HYPROMELLOSE, UNSPECIFIED
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
Product Characteristics
Color GREEN Score 2 pieces
Shape CAPSULE Size 17mm
Flavor Imprint Code 131
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42799-131-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:42799-131-02 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211596 10/29/2018
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42799-132
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 120 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYDROXYPROPYL CELLULOSE
HYPROMELLOSE, UNSPECIFIED
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score 2 pieces
Shape CAPSULE Size 19mm
Flavor Imprint Code 132
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42799-132-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211596 10/29/2018
Labeler — Edenbridge Pharmaceuticals LLC. (948715060)

Revised: 11/2021 Edenbridge Pharmaceuticals LLC.

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