NDC 69036-503

LODINE

Etodolac

LODINE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sallus Laboratories, Llc. The primary component is Etodolac.

Product ID69036-503_6f96a3de-40f5-4d0d-9a6c-3d7fcddfd77c
NDC69036-503
Product TypeHuman Prescription Drug
Proprietary NameLODINE
Generic NameEtodolac
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA075074
Labeler NameSallus Laboratories, LLC
Substance NameETODOLAC
Active Ingredient Strength400 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 69036-503-30

30 TABLET, FILM COATED in 1 BOTTLE (69036-503-30)
Marketing Start Date2016-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69036-503-30 [69036050330]

LODINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075074
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ETODOLAC400 mg/1

OpenFDA Data

SPL SET ID:560ffd3c-47c9-4ee3-8f92-07629066ca29
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 206812
  • 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]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]

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

    NDCBrand NameGeneric Name
    69036-503LODINELODINE
    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

    Trademark Results [LODINE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LODINE
    LODINE
    98499210 not registered Live/Pending
    Galt Pharmaceuticals, LLC
    2024-04-14
    LODINE
    LODINE
    87137124 5129189 Live/Registered
    Cutis Health, LLC
    2016-08-12
    LODINE
    LODINE
    78359563 3023014 Dead/Cancelled
    SHIONOGI INC.
    2004-01-29
    LODINE
    LODINE
    76232699 2512709 Dead/Cancelled
    American Home Products Corporation
    2001-03-28
    LODINE
    LODINE
    74175962 1736010 Dead/Cancelled
    AMERICAN HOME PRODUCTS CORPORATION
    1991-06-14
    LODINE
    LODINE
    73807418 1581039 Dead/Cancelled
    AMERICAN HOME PRODUCTS CORPORATION
    1989-06-19

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