NDC Code(s) : 55154-5091-0
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diltiazem Hydrochloridediltiazem hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5091(NDC:51079-948)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE)
(DILTIAZEM - UNII:EE92BBP03H) 		DILTIAZEM HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
OLEIC ACID(UNII: 2UMI9U37CP)
AMMONIUM LAURETH-5 SULFATE(UNII: 43ZIH89I48)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C RED NO. 28(UNII: 767IP0Y5NH)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color PURPLE (lavender opaque), PINK (flesh opaque) Score no score
Shape CAPSULE Size 15 mm
Flavor Imprint Code MYLAN;5280
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-5091-010 in 1 BAG
11 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075124 07/11/2011

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 180 mg

DILTIAZEM
HYDROCHLORIDE
EXTENDED-RELEASE
CAPSULES, USP
(Once-a-Day Dosage)
180 mg

 10 Capsules  

bag label