NDC 68788-9928

Etodolac

Etodolac

Etodolac is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Etodolac.

Product ID68788-9928_07db299c-cb3f-4cf6-b629-b1b7f772e8ab
NDC68788-9928
Product TypeHuman Prescription Drug
Proprietary NameEtodolac
Generic NameEtodolac
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-01-18
Marketing CategoryANDA / ANDA
Application NumberANDA075009
Labeler NamePreferred Pharmaceuticals, Inc.
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 68788-9928-9

90 TABLET, FILM COATED in 1 BOTTLE (68788-9928-9)
Marketing Start Date2012-01-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9928-2 [68788992802]

Etodolac TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075009
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-01-18
Marketing End Date2019-09-13

NDC 68788-9928-1 [68788992801]

Etodolac TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075009
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-01-18
Marketing End Date2019-09-13

NDC 68788-9928-8 [68788992808]

Etodolac TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075009
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-01-18
Marketing End Date2019-09-13

NDC 68788-9928-3 [68788992803]

Etodolac TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075009
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-01-18
Marketing End Date2019-09-13

NDC 68788-9928-6 [68788992806]

Etodolac TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075009
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-01-18
Marketing End Date2019-09-13

NDC 68788-9928-9 [68788992809]

Etodolac TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075009
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-01-18
Marketing End Date2019-09-13

Drug Details

Active Ingredients

IngredientStrength
ETODOLAC400 mg/1

OpenFDA Data

SPL SET ID:62e9b4a2-868d-45ea-af45-f193e7ad52bc
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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