NDC 61919-401

AMOXICILLIN

Amoxicillin

AMOXICILLIN is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Amoxicillin.

Product ID61919-401_1a440784-8037-4a8a-9f4a-cd5ec463e3bf
NDC61919-401
Product TypeHuman Prescription Drug
Proprietary NameAMOXICILLIN
Generic NameAmoxicillin
Dosage FormPowder, For Suspension
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA065334
Labeler NameDIRECT RX
Substance NameAMOXICILLIN
Active Ingredient Strength400 mg/5mL
Pharm ClassesPenicillin-class Antibacterial [EPC],Penicillins [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-401-32

100 mL in 1 BOTTLE (61919-401-32)
Marketing Start Date2020-06-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-401-32 [61919040132]

AMOXICILLIN POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA065334
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
AMOXICILLIN400 mg/5mL

OpenFDA Data

SPL SET ID:0173e9de-a995-4386-bb65-8fc2bbf347f9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308189
  • Pharmacological Class

    • Penicillin-class Antibacterial [EPC]
    • Penicillins [CS]

    NDC Crossover Matching brand name "AMOXICILLIN" or generic name "Amoxicillin"

    NDCBrand NameGeneric Name
    0093-2263AmoxicillinAmoxicillin
    0093-2264AmoxicillinAmoxicillin
    0093-2267AmoxicillinAmoxicillin
    0093-2268AmoxicillinAmoxicillin
    0093-3107AmoxicillinAmoxicillin
    0093-3109AmoxicillinAmoxicillin
    0093-4150AmoxicillinAmoxicillin
    0093-4155AmoxicillinAmoxicillin
    0093-4160AmoxicillinAmoxicillin
    0093-4161AmoxicillinAmoxicillin
    0143-9285AmoxicillinAmoxicillin
    0143-9820AmoxicillinAmoxicillin
    0143-9821AmoxicillinAmoxicillin
    0143-9886AmoxicillinAmoxicillin
    0143-9887AmoxicillinAmoxicillin
    0143-9888AmoxicillinAmoxicillin
    68071-1675AmoxicillinAmoxicillin
    68071-1760AmoxicillinAmoxicillin
    68071-1817AmoxicillinAmoxicillin
    68071-1526AmoxicillinAmoxicillin
    68071-1761AmoxicillinAmoxicillin
    68071-1789AmoxicillinAmoxicillin
    68071-3292AmoxicillinAmoxicillin
    68071-3339AmoxicillinAmoxicillin
    68071-3343AmoxicillinAmoxicillin
    68071-3235AmoxicillinAmoxicillin
    68071-4086AmoxicillinAmoxicillin
    68071-3119AmoxicillinAmoxicillin
    68071-4064AmoxicillinAmoxicillin
    68071-4192AmoxicillinAmoxicillin
    68071-4079AmoxicillinAmoxicillin
    68071-4189AmoxicillinAmoxicillin
    68071-4468AmoxicillinAmoxicillin
    68071-4548AmoxicillinAmoxicillin
    68071-4338AmoxicillinAmoxicillin
    68071-4455AmoxicillinAmoxicillin
    68071-4196AmoxicillinAmoxicillin
    68071-4693AmoxicillinAmoxicillin
    68071-4418AmoxicillinAmoxicillin
    68071-4724AmoxicillinAmoxicillin
    68071-4581AmoxicillinAmoxicillin
    68071-4574AmoxicillinAmoxicillin
    68071-4567AmoxicillinAmoxicillin
    68071-4734AmoxicillinAmoxicillin
    68071-4796AmoxicillinAmoxicillin
    68071-4696AmoxicillinAmoxicillin
    68071-4698AmoxicillinAmoxicillin
    68071-4741AmoxicillinAmoxicillin
    68071-4704AmoxicillinAmoxicillin
    0440-7100AmoxicillinAmoxicillin

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