NDC 61919-665

AMOXICILLIN CLAV/POT

Amoxicillin Clav/pot

AMOXICILLIN CLAV/POT is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Clavulanate Potassium; Amoxicillin.

Product ID61919-665_8385b73e-08c0-d697-e053-2a91aa0a9f8f
NDC61919-665
Product TypeHuman Prescription Drug
Proprietary NameAMOXICILLIN CLAV/POT
Generic NameAmoxicillin Clav/pot
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA204755
Labeler NameDIRECT RX
Substance NameCLAVULANATE POTASSIUM; AMOXICILLIN
Active Ingredient Strength125 mg/1; mg/1
Pharm Classesbeta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-665-14

14 TABLET, FILM COATED in 1 BOTTLE (61919-665-14)
Marketing Start Date2018-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-665-20 [61919066520]

AMOXICILLIN CLAV/POT TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204755
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-31

NDC 61919-665-14 [61919066514]

AMOXICILLIN CLAV/POT TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204755
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-31

Drug Details

Active Ingredients

IngredientStrength
CLAVULANATE POTASSIUM125 mg/1

OpenFDA Data

SPL SET ID:7989371d-feed-6c25-e053-2991aa0a967d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 562508

    • Pharmacological Class

    • beta Lactamase Inhibitor [EPC]
    • beta Lactamase Inhibitors [MoA]
    • Penicillin-class Antibacterial [EPC]
    • Penicillins [CS]
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