Diltiazem Hydrochloride (Page 6 of 6)

Storage conditions:

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Avoid excessive humidity. Dispense in tight containers with safety closures.

Distributed by:

PuraCap Laboratories, LLC

DBA Blu Pharmaceuticals

Franklin, KY 42134 USA

1-877-264-0258

Revised: March 2017

341032017

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 120 mg

Dilitiazem HCl Extended-Release Capsules, USP

120 mg

Once-A-Day

Rx Only

diltiazem-120mg-30s
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 180 mg

Dilitiazem HCl Extended-Release Capsules, USP

180 mg

Once-A-Day

Rx Only

diltiazem-180mg-30s
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 240 mg

Dilitiazem HCl Extended-Release Capsules, USP

240 mg

Once-A-Day

Rx Only

diltiazem-240mg-30s
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 300 mg

Dilitiazem HCl Extended-Release Capsules, USP

300 mg

Once-A-Day

Rx Only

diltiazem-300mg-30s
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Dilitiazem HCl Extended-Release Capsules, USP

360 mg

Once-A-Day

Rx Only

diltiazem-360mg-30s
(click image for full-size original)

DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-341(NDC:62037-696)
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
FERROSOFERRIC OXIDE
STARCH, CORN
ETHYLCELLULOSE (10 MPA.S)
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
NONOXYNOL-100
POLYSORBATE 80
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SUCROSE
TALC
TITANIUM DIOXIDE
D&C RED NO. 28
SHELLAC
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)
HYPROMELLOSE 2910 (5 MPA.S)
Product Characteristics
Color pink (pink opaque) , pink (pink opaque) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code Andrx;696;120;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-341-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:24658-341-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075401 04/10/2003
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-342(NDC:62037-697)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 180 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
STARCH, CORN
ETHYLCELLULOSE (10 MPA.S)
D&C YELLOW NO. 10
ALUMINUM OXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
NONOXYNOL-100
SHELLAC
POLYSORBATE 80
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SUCROSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color blue (light blu opaque) , brown (buff opaque) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code Andrx;697;180;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-342-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:24658-342-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075401 04/10/2003
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-343(NDC:62037-698)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 240 mg
Inactive Ingredients
Ingredient Name Strength
NONOXYNOL-100
SHELLAC
POLYSORBATE 80
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SUCROSE
TALC
TITANIUM DIOXIDE
ALUMINUM OXIDE
FERROSOFERRIC OXIDE
STARCH, CORN
ETHYLCELLULOSE (10 MPA.S)
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
Product Characteristics
Color pink (pink opaque) , blue (light blue) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code Andrx;698;240;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-343-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:24658-343-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075401 04/10/2003
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-344(NDC:62037-699)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 300 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
STARCH, CORN
ETHYLCELLULOSE (10 MPA.S)
D&C RED NO. 28
D&C YELLOW NO. 10
ALUMINUM OXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
NONOXYNOL-100
SHELLAC
POLYSORBATE 80
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SUCROSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color pink (pink opaque) , brown (buff opaque) Score no score
Shape CAPSULE (CAPSULE) Size 23mm
Flavor Imprint Code Andrx;699;300;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-344-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:24658-344-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075401 04/10/2003
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-345(NDC:62037-700)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 360 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
STARCH, CORN
ETHYLCELLULOSE (10 MPA.S)
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
NONOXYNOL-100
SHELLAC
POLYSORBATE 80
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SUCROSE
TALC
TITANIUM DIOXIDE
ALUMINUM OXIDE
Product Characteristics
Color blue (light blue opaque) , blue (light blue opaque) Score no score
Shape CAPSULE (CAPSULE) Size 23mm
Flavor Imprint Code Andrx;700;360;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-345-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:24658-345-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075401 04/10/2003
Labeler — PuraCap Laboratories LLC dba Blu Pharmaceuticals (080210964)
Registrant — PuraCap Laboratories LLC dba Blu Pharmaceuticals (080210964)
Establishment
Name Address ID/FEI Operations
PuraCap Laboratories LLC dba Blu Pharmaceuticals 080210964 repack (24658-341), repack (24658-342), repack (24658-343), repack (24658-344), repack (24658-345)

Revised: 01/2019 PuraCap Laboratories LLC dba Blu Pharmaceuticals

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