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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 180 mg

Dilitiazem HCl Extended-Release Capsules, USP

180 mg

Once-A-Day

Rx Only

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 240 mg

Dilitiazem HCl Extended-Release Capsules, USP

240 mg

Once-A-Day

Rx Only

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 300 mg

Dilitiazem HCl Extended-Release Capsules, USP

300 mg

Once-A-Day

Rx Only

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Dilitiazem HCl Extended-Release Capsules, USP

360 mg

Once-A-Day

Rx Only

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