NDC 69399-183

Celecoxib 100 mg

Celecoxib

Celecoxib 100 mg is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sydon Labs Llc. The primary component is Celecoxib.

Product ID69399-183_32296228-f1f7-4272-b8d4-affca2a3d287
NDC69399-183
Product TypeHuman Prescription Drug
Proprietary NameCelecoxib 100 mg
Generic NameCelecoxib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-11-24
Marketing CategoryANDA / ANDA
Application NumberANDA204519
Labeler NameSYDON LABS LLC
Substance NameCELECOXIB
Active Ingredient Strength100 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 69399-183-81

100 CAPSULE in 1 BOTTLE (69399-183-81)
Marketing Start Date2015-11-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69399-183-81 [69399018381]

Celecoxib 100 mg CAPSULE
Marketing CategoryANDA
Application NumberANDA204519
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-24
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CELECOXIB100 mg/1

OpenFDA Data

SPL SET ID:457eb10a-1188-4c43-a147-d258517342e8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205322
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • UPC Code
  • 0369399183818
  • 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 "Celecoxib 100 mg" or generic name "Celecoxib"

    NDCBrand NameGeneric Name
    69399-183Celecoxib 100 mgCelecoxib 100 mg
    0025-1515CELEBREXCelecoxib
    0025-1520CELEBREXCelecoxib
    0025-1525CELEBREXCelecoxib
    0025-1530CELEBREXCelecoxib
    0093-7165CelecoxibCelecoxib
    0093-7166CelecoxibCelecoxib
    0093-7170CelecoxibCelecoxib
    0093-7306CelecoxibCelecoxib

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