Doxycycline hyclate capsule

Spl unclassified section

Relabeling and Repackaging by:
STAT Rx USA LLC
Gainesville, GA 30501

Ingredients and appearance - Product information

Doxycycline hyclate capsule- Doxycycline hyclate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 16590-299
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Doxycycline hyclate ( UNII: 19XTS3T51U)( Doxycycline anhydrous - UNII: 334895S862 ) 50 mgin 1

Inactive Ingredients

Ingredient Name Code
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Magnesium stearate ( UNII: 70097M6I30)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color BLUE (BLUE/WHITE) Imprint Code WestWard;3141
Score 1 Shape CAPSULE (CAPSULE)
Size 9 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA062396 USA

Doxycycline hyclate capsule- Doxycycline hyclate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 16590-082
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Doxycycline hyclate ( UNII: 19XTS3T51U)( Doxycycline anhydrous - UNII: 334895S862 ) 100 mgin 1

Inactive Ingredients

Ingredient Name Code
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Magnesium stearate ( UNII: 70097M6I30)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color BLUE (BLUE) Imprint Code Westward;3142
Score 1 Shape CAPSULE
Size 9 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA062396 USA

Labeler - STAT Rx USA LLC( 786036330)

Establishment

Name ID/FEI Business Operations
STAT Rx USA LLC 786036330 relabel( 16590-299, 16590-299), repack( 16590-082, 16590-082)

Package label - doxycycline 50 mg capsules

Package label - doxycycline 100 mg capsules