NDC 35356-826

Etodolac

Etodolac

Etodolac is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Etodolac.

Product ID35356-826_1d4d5ad3-394b-4574-b4d3-f35eec6bebb5
NDC35356-826
Product TypeHuman Prescription Drug
Proprietary NameEtodolac
Generic NameEtodolac
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1998-05-20
Marketing CategoryANDA / ANDA
Application NumberANDA075009
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameETODOLAC
Active Ingredient Strength400 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 35356-826-28

28 TABLET, FILM COATED in 1 BOTTLE (35356-826-28)
Marketing Start Date1998-05-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-826-14 [35356082614]

Etodolac TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075009
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-05-20
Marketing End Date2018-12-31

NDC 35356-826-28 [35356082628]

Etodolac TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075009
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-05-20
Marketing End Date2018-12-31

NDC 35356-826-40 [35356082640]

Etodolac TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075009
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-05-20
Marketing End Date2018-12-31

NDC 35356-826-30 [35356082630]

Etodolac TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075009
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-05-20
Marketing End Date2018-12-31

NDC 35356-826-60 [35356082660]

Etodolac TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075009
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-05-20
Marketing End Date2018-12-31

NDC 35356-826-90 [35356082690]

Etodolac TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075009
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-05-20
Marketing End Date2018-12-31

Drug Details

Active Ingredients

IngredientStrength
ETODOLAC400 mg/1

OpenFDA Data

SPL SET ID:1714328a-3e1a-45e0-83a8-1813c5c7f1f8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197686
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    NDC Crossover Matching brand name "Etodolac" or generic name "Etodolac"

    NDCBrand NameGeneric Name
    0093-0892EtodolacEtodolac
    0093-1118EtodolacEtodolac
    0093-1122EtodolacEtodolac
    0093-1893EtodolacEtodolac
    0093-7172EtodolacEtodolac
    0185-0675EtodolacEtodolac
    0185-0687EtodolacEtodolac
    10544-862EtodolacEtodolac
    16714-497EtodolacEtodolac
    16714-498EtodolacEtodolac
    16714-499EtodolacEtodolac
    21695-049EtodolacEtodolac
    21695-050EtodolacEtodolac
    33261-043EtodolacEtodolac
    33261-044EtodolacEtodolac
    35356-324EtodolacEtodolac
    35356-711EtodolacEtodolac
    35356-826EtodolacEtodolac
    42254-052EtodolacEtodolac
    42254-121Etodolacetodolac
    42291-404EtodolacEtodolac
    42291-405EtodolacEtodolac
    42799-111EtodolacEtodolac
    68151-0738EtodolacEtodolac
    68382-273EtodolacEtodolac
    68382-271EtodolacEtodolac
    68382-272EtodolacEtodolac
    68788-6901EtodolacEtodolac
    68788-9410EtodolacEtodolac
    68788-7315EtodolacEtodolac
    68788-7300EtodolacEtodolac
    68788-7068EtodolacEtodolac
    68788-9928EtodolacEtodolac
    68788-9929EtodolacEtodolac
    68788-9360EtodolacEtodolac
    68788-9990EtodolacEtodolac
    68788-9930EtodolacEtodolac
    69238-1342EtodolacEtodolac
    69238-1343EtodolacEtodolac
    70332-320EtodolacEtodolac
    71335-0092EtodolacEtodolac
    71335-0183EtodolacEtodolac
    71335-0399EtodolacEtodolac
    71335-0602EtodolacEtodolac
    71335-0640EtodolacEtodolac
    71335-0126EtodolacEtodolac
    71335-0982EtodolacEtodolac
    43063-578EtodolacEtodolac
    42799-112EtodolacEtodolac
    43063-671EtodolacEtodolac
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