NDC 61919-211

SUNLINDAC

Sulindac

SUNLINDAC is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Sulindac.

Product ID61919-211_43ca706a-27e1-2f93-e054-00144ff88e88
NDC61919-211
Product TypeHuman Prescription Drug
Proprietary NameSUNLINDAC
Generic NameSulindac
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA072051
Labeler NameDirect Rx
Substance NameSULINDAC
Active Ingredient Strength200 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-211-30

30 TABLET in 1 BOTTLE (61919-211-30)
Marketing Start Date2014-04-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-211-30 [61919021130]

SUNLINDAC TABLET
Marketing CategoryANDA
Application NumberANDA072051
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-02

NDC 61919-211-20 [61919021120]

SUNLINDAC TABLET
Marketing CategoryANDA
Application NumberANDA072051
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-02
Marketing End Date2016-09-28

Drug Details

Active Ingredients

IngredientStrength
SULINDAC200 mg/1

OpenFDA Data

SPL SET ID:13a2cdb5-580f-470e-8b64-cc22ed56a8bb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198239
  • 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]

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

    NDCBrand NameGeneric Name
    61919-211SUNLINDACSUNLINDAC
    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

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