NDC 0378-0531

Sulindac

Sulindac

Sulindac is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Sulindac.

Product ID0378-0531_038acf5f-64ac-423c-aeb5-b3f2ae9014d0
NDC0378-0531
Product TypeHuman Prescription Drug
Proprietary NameSulindac
Generic NameSulindac
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1993-06-22
Marketing End Date2021-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA073039
Labeler NameMylan Pharmaceuticals Inc.
Substance NameSULINDAC
Active Ingredient Strength200 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN

Packaging

NDC 0378-0531-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0531-01)
Marketing Start Date1993-06-22
Marketing End Date2021-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0531-01 [00378053101]

Sulindac TABLET
Marketing CategoryANDA
Application NumberANDA073039
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1993-06-22

Drug Details

Active Ingredients

IngredientStrength
SULINDAC200 mg/1

OpenFDA Data

SPL SET ID:473edb3e-ccaa-4a74-8dc8-6a053c52d3e0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198239
  • 198238
  • 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]
    • Cyclooxygenase Inhibitors [MoA]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    NDC Crossover Matching brand name "Sulindac" or generic name "Sulindac"

    NDCBrand NameGeneric Name
    0378-0427Sulindacsulindac
    0378-0531Sulindacsulindac
    0591-5660SulindacSulindac
    0591-5661SulindacSulindac
    0904-6216SulindacSulindac
    0904-6217SulindacSulindac
    23155-005SulindacSulindac
    23155-006SulindacSulindac
    24658-770SULINDACSULINDAC
    24658-771SULINDACSULINDAC
    33261-100SulindacSulindac
    42806-011SULINDACSULINDAC
    42806-018SULINDACSULINDAC
    50090-0528SulindacSulindac
    50090-0529SULINDACSULINDAC
    50090-2093SULINDACsulindac
    50090-4976SulindacSulindac
    51079-667Sulindacsulindac
    52959-195SulindacSulindac
    53489-478SULINDACsulindac
    53489-479SULINDACsulindac
    68151-2871SulindacSulindac
    68151-2872SulindacSulindac
    71335-0535SULINDACSULINDAC
    71335-0413SULINDACSULINDAC
    53808-0302SULINDACSULINDAC
    53808-0303SulindacSulindac
    54738-902SulindacSulindac
    53808-0814SulindacSulindac
    53808-0799SulindacSulindac
    54738-903SulindacSulindac
    55289-930SulindacSulindac
    55700-682SULINDACSULINDAC
    60429-697SULINDACSULINDAC
    60429-698SULINDACSULINDAC
    63629-3208SulindacSulindac
    70934-550SulindacSulindac

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