Amoxicillin capsule

Ingredients and appearance - Product information

Amoxicillin capsule- Amoxicillin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 55289-019
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Amoxicillin ( UNII: 804826J2HU)( Amoxicillin anhydrous - UNII: 9EM05410Q9 ) 250 mgin 1

Inactive Ingredients

Ingredient Name Code
Magnesium stearate ( UNII: 70097M6I30)
Talc ( UNII: 7SEV7J4R1U)
Ferrosoferric oxide ( UNII: XM0M87F357)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Gelatin ( UNII: 2G86QN327L)
Propylene glycol ( UNII: 6DC9Q167V3)
Shellac ( UNII: 46N107B71O)
Titanium dioxide ( UNII: 15FIX9V2JP)
D&c red no. 28 ( UNII: 767IP0Y5NH)

Product Characteristics

Color brown (buff) Imprint Code TEVA;3107
Score 1 Shape CAPSULE
Size 18 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 55289-019-06 6 in 1 BOTTLE, PLASTIC 2011/11/28
2 NDC: 55289-019-15 15 in 1 BOTTLE, PLASTIC 2011/11/28
3 NDC: 55289-019-21 21 in 1 BOTTLE, PLASTIC 2011/11/28
4 NDC: 55289-019-24 24 in 1 BOTTLE, PLASTIC 2011/11/28
5 NDC: 55289-019-30 30 in 1 BOTTLE, PLASTIC 2011/11/28
6 NDC: 55289-019-40 40 in 1 BOTTLE, PLASTIC 2011/11/28
7 NDC: 55289-019-60 60 in 1 BOTTLE, PLASTIC 2011/11/28

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA061926 USA 2011/11/28

Labeler - PD-Rx Pharmaceuticals, Inc.( 156893695)

Establishment

Name ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack( 55289-019)