NDC 65841-778

Etodolac

Etodolac

Etodolac is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Etodolac.

Product ID65841-778_3f65753d-4399-44ea-8b40-16eaae29d3be
NDC65841-778
Product TypeHuman Prescription Drug
Proprietary NameEtodolac
Generic NameEtodolac
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-02-15
Marketing CategoryANDA / ANDA
Application NumberANDA091134
Labeler NameZydus Lifesciences Limited
Substance NameETODOLAC
Active Ingredient Strength500 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 65841-778-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-778-01)
Marketing Start Date2014-02-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65841-778-05 [65841077805]

Etodolac TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-15

NDC 65841-778-14 [65841077814]

Etodolac TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-15

NDC 65841-778-30 [65841077830]

Etodolac TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-15

NDC 65841-778-77 [65841077877]

Etodolac TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-15

NDC 65841-778-01 [65841077801]

Etodolac TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-15

NDC 65841-778-10 [65841077810]

Etodolac TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-15

Drug Details

Active Ingredients

IngredientStrength
ETODOLAC500 mg/1

OpenFDA Data

SPL SET ID:0c5f8631-f013-4bbb-b610-0a8a1311844e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 359500
  • 310245
  • 310247
    • 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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