NDC 52959-649

Etodolac

Etodolac

Etodolac is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Etodolac.

Product ID52959-649_5566541f-5f89-2902-e054-00144ff88e88
NDC52959-649
Product TypeHuman Prescription Drug
Proprietary NameEtodolac
Generic NameEtodolac
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-03-06
Marketing CategoryANDA / ANDA
Application NumberANDA091134
Labeler NameH.J. HARKINS COMPANY, INC.
Substance NameETODOLAC
Active Ingredient Strength500 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52959-649-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 VIAL (52959-649-30)
Marketing Start Date2017-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-649-15 [52959064915]

Etodolac TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-06
Inactivation Date2020-01-31

NDC 52959-649-30 [52959064930]

Etodolac TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091134
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-06
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ETODOLAC500 mg/1

OpenFDA Data

SPL SET ID:5566541f-5f88-2902-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 359500
    • 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]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]

    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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