NDC 53002-2160

Amoxicillin

Amoxicillin

Amoxicillin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Amoxicillin.

Product ID53002-2160_22630ff3-9448-4b49-b7d7-abf20dd827f0
NDC53002-2160
Product TypeHuman Prescription Drug
Proprietary NameAmoxicillin
Generic NameAmoxicillin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2005-11-09
Marketing CategoryANDA / ANDA
Application NumberANDA065271
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameAMOXICILLIN
Active Ingredient Strength500 mg/1
Pharm ClassesPenicillin-class Antibacterial [EPC],Penicillins [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53002-2160-1

9 CAPSULE in 1 BOTTLE (53002-2160-1)
Marketing Start Date2017-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-2160-1 [53002216001]

Amoxicillin CAPSULE
Marketing CategoryANDA
Application NumberANDA065271
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31
Reactivation Date2020-02-19

NDC 53002-2160-2 [53002216002]

Amoxicillin CAPSULE
Marketing CategoryANDA
Application NumberANDA065271
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31
Reactivation Date2020-02-19

NDC 53002-2160-5 [53002216005]

Amoxicillin CAPSULE
Marketing CategoryANDA
Application NumberANDA065271
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31
Reactivation Date2020-02-19

NDC 53002-2160-3 [53002216003]

Amoxicillin CAPSULE
Marketing CategoryANDA
Application NumberANDA065271
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31
Reactivation Date2020-02-19

NDC 53002-2160-6 [53002216006]

Amoxicillin CAPSULE
Marketing CategoryANDA
Application NumberANDA065271
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31
Reactivation Date2020-02-19

NDC 53002-2160-4 [53002216004]

Amoxicillin CAPSULE
Marketing CategoryANDA
Application NumberANDA065271
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31
Reactivation Date2020-02-19

Drug Details

Active Ingredients

IngredientStrength
AMOXICILLIN500 mg/1

OpenFDA Data

SPL SET ID:23979212-e989-4a8e-8dc8-46c5b4ecd590
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308191
  • 308182

    • 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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