NDC 68788-6393

CELECOXIB

Celecoxib

CELECOXIB is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Celecoxib.

Product ID68788-6393_827afd12-042d-4981-a2c4-ab3431c2cff2
NDC68788-6393
Product TypeHuman Prescription Drug
Proprietary NameCELECOXIB
Generic NameCelecoxib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-05-23
Marketing CategoryANDA / ANDA
Application NumberANDA207446
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameCELECOXIB
Active Ingredient Strength200 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68788-6393-8

120 CAPSULE in 1 BOTTLE (68788-6393-8)
Marketing Start Date2016-05-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-6393-8 [68788639308]

CELECOXIB CAPSULE
Marketing CategoryANDA
Application NumberANDA207446
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-23
Marketing End Date2019-07-17

NDC 68788-6393-6 [68788639306]

CELECOXIB CAPSULE
Marketing CategoryANDA
Application NumberANDA207446
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-23
Marketing End Date2019-07-17

NDC 68788-6393-9 [68788639309]

CELECOXIB CAPSULE
Marketing CategoryANDA
Application NumberANDA207446
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-23
Marketing End Date2019-07-17

NDC 68788-6393-1 [68788639301]

CELECOXIB CAPSULE
Marketing CategoryANDA
Application NumberANDA207446
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-23
Marketing End Date2019-07-17

NDC 68788-6393-3 [68788639303]

CELECOXIB CAPSULE
Marketing CategoryANDA
Application NumberANDA207446
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-23
Marketing End Date2019-07-17

Drug Details

Active Ingredients

IngredientStrength
CELECOXIB200 mg/1

OpenFDA Data

SPL SET ID:0eaa644f-2cc7-405f-be8a-b640f012ba3d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205323
  • 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 "CELECOXIB" or generic name "Celecoxib"

    NDCBrand NameGeneric Name
    0093-7165CelecoxibCelecoxib
    0093-7166CelecoxibCelecoxib
    0093-7170CelecoxibCelecoxib
    0093-7306CelecoxibCelecoxib
    68071-2164CelecoxibCelecoxib
    68071-2169CelecoxibCelecoxib
    68071-4252CelecoxibCelecoxib
    68071-4392celecoxibcelecoxib
    68071-4642CELECOXIBCELECOXIB
    68071-4476CelecoxibCelecoxib
    68084-976CelecoxibCelecoxib
    68084-969CelecoxibCelecoxib
    68180-395celecoxibcelecoxib
    68180-396celecoxibcelecoxib
    68180-398celecoxibcelecoxib
    68180-397celecoxibcelecoxib
    68788-6393CELECOXIBCELECOXIB
    68788-6463CelecoxibCelecoxib
    68788-6941CelecoxibCelecoxib
    68788-9274CelecoxibCelecoxib
    68788-8936CelecoxibCelecoxib
    68788-7134CelecoxibCelecoxib
    68788-8924CelecoxibCelecoxib
    68788-9273CelecoxibCelecoxib
    68788-9993CelecoxibCelecoxib
    69097-421CELECOXIBCELECOXIB
    69097-420CELECOXIBCELECOXIB
    69097-422CELECOXIBCELECOXIB
    69097-423CELECOXIBCELECOXIB
    69677-154CelecoxibCelecoxib
    70518-1346celecoxibcelecoxib
    0591-3982CelecoxibCelecoxib
    70518-1650celecoxibcelecoxib
    0591-3984CelecoxibCelecoxib
    0591-3985CelecoxibCelecoxib
    0591-3983CelecoxibCelecoxib
    70882-129CelecoxibCelecoxib
    70934-026CelecoxibCelecoxib
    71205-020CelecoxibCelecoxib
    71205-027celecoxibcelecoxib
    71205-055CelecoxibCelecoxib
    71335-0361CelecoxibCelecoxib
    71335-0597CelecoxibCelecoxib
    71335-0936celecoxibcelecoxib
    71335-0868celecoxibcelecoxib
    71335-0292CelecoxibCelecoxib
    71335-0450CELECOXIBCELECOXIB
    71335-0437CelecoxibCelecoxib
    71626-302CelecoxibCelecoxib
    71626-303CelecoxibCelecoxib

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.