NDC 0185-0675

Etodolac

Etodolac

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

Product ID0185-0675_1ad440d5-7e56-4d98-ba75-56eac1fafb01
NDC0185-0675
Product TypeHuman Prescription Drug
Proprietary NameEtodolac
Generic NameEtodolac
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2015-04-20
Marketing CategoryANDA / ANDA
Application NumberANDA074903
Labeler NameEon Labs, Inc.
Substance NameETODOLAC
Active Ingredient Strength400 mg/1
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0185-0675-01

100 TABLET, COATED in 1 BOTTLE (0185-0675-01)
Marketing Start Date2015-04-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0185-0675-01 [00185067501]

Etodolac TABLET, COATED
Marketing CategoryANDA
Application NumberANDA074903
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-04-20

NDC 0185-0675-05 [00185067505]

Etodolac TABLET, COATED
Marketing CategoryANDA
Application NumberANDA074903
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-20

NDC 0185-0675-10 [00185067510]

Etodolac TABLET, COATED
Marketing CategoryANDA
Application NumberANDA074903
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-04-20

Drug Details

Active Ingredients

IngredientStrength
ETODOLAC400 mg/1

OpenFDA Data

SPL SET ID:ba37476d-05a4-48cb-9cee-6b10e0dd5bf4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197686
  • 199390
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0301850675012
    • 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]
    • Cyclooxygenase Inhibitors [MoA]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.