NDC Code(s) : 54569-4914-0, 54569-4914-1
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-4914(NDC:49884-830)
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
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
AMMONIA(UNII: 5138Q19F1X)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
GELATIN(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIMETHICONE(UNII: 92RU3N3Y1O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
SHELLAC(UNII: 46N107B71O)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
Product Characteristics
Color GREEN (dark-green cap), BLUE (agua-blue body) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code R;2577
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-4914-030 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:54569-4914-190 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074984 12/20/1999

PRINCIPAL DISPLAY PANEL

2268b074-figure-01