Diltiazem hydrochloride capsule, extended release

Ingredients and appearance - Product information

Diltiazem hydrochloride capsule, extended release- Diltiazem hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 49349-317
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diltiazem hydrochloride ( UNII: OLH94387TE)( Diltiazem - UNII: EE92BBP03H ) 180 mgin 1

Inactive Ingredients

Ingredient Name Code
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)
Polyethylene glycol ( UNII: 3WJQ0SDW1A)
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 pink Score 1
Shape CAPSULE (CAPSULE, EXTENDED RELEASE) Imprint Code MYLAN;5280
Size 15 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 49349-317-02 30 in 1 BLISTER PACK 2011/06/21

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075124 USA 2011/06/21

Labeler - REMEDYREPACK INC.( 829572556)