Minocycline hydrochloride capsule

Repackaging information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 100mg
3600 43353-105-83

Store between 20-25C (68-77F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20160628DH

Ingredients and appearance - Product information

Minocycline hydrochloride capsule- Minocycline hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 43353-105
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Minocycline hydrochloride ( UNII: 0020414E5U)( Minocycline - UNII: FYY3R43WGO ) 100 mgin 1

Inactive Ingredients

Ingredient Name Code
Magnesium stearate ( UNII: 70097M6I30)
Starch, corn ( UNII: O8232NY3SJ)
D&c red no. 28 ( UNII: 767IP0Y5NH)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Gelatin ( UNII: 2G86QN327L)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Titanium dioxide ( UNII: 15FIX9V2JP)
Ferrosoferric oxide ( UNII: XM0M87F357)

Product Characteristics

Color YELLOW (Yellow Opaque) Imprint Code MINOCYCLINE;100;DAN;5695
Score 1 Shape CAPSULE
Size 18 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 43353-105-83 3600 in 1 BOTTLE, PLASTIC 2015/10/02

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA063065 USA 2015/10/02

Labeler - Aphena Pharma Solutions - Tennessee, LLC( 128385585)

Establishment

Name ID/FEI Business Operations
Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK( 43353-105)