Label: AMOXICILLIN capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 61919-355-30 - Packager: DIRECTRX
- This is a repackaged label.
- Source NDC Code(s): 67253-150
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 13, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
- 6 ADVERSE REACTIONS
- 7 DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
- 14 CLINICAL STUDIES
- 13 NONCLINICAL TOXICOLOGY
- 15 REFERENCES
- 17 PATIENT COUNSELING INFORMATION
- 500 mg Capsule Label
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INGREDIENTS AND APPEARANCE
AMOXICILLIN
amoxicillin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-355(NDC:67253-150) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS 500 mg Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SHELLAC (UNII: 46N107B71O) AMMONIA (UNII: 5138Q19F1X) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ALCOHOL (UNII: 3K9958V90M) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GELATIN (UNII: 2G86QN327L) Product Characteristics Color yellow (Opaque) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code AMOX;500;GG;849 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-355-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064076 04/11/2016 Labeler - DIRECTRX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 repack(61919-355)